End effector updates

ABSTRACT

Examples herein describes a powered surgical end-effector that may include a controllable jaw configured to operate on a tissue, an updatable memory having stored therein a default actuation algorithm, and and a processor. The processor may be configured to operate in a first mode at a first time, wherein in the first mode the processor may be configured to operate an aspect of the controllable jaw according to the default actuation algorithm. The processor may receive data at a second time, after the first time, that may cause the processor to operate in a second mode, wherein in the second mode the processor may be configured to operate an aspect of the controllable jaw according to an alternative actuation algorithm.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is related to the following, filed contemporaneously,the contents of each of which are incorporated by reference herein:

-   Attorney Docket No. END9287ISNP1, titled METHOD FOR OPERATING TIERED    OPERATION MODES IN A SURGICAL SYSTEM.

BACKGROUND

Surgical systems often incorporate an imaging system, which can allowthe clinician(s) to view the surgical site and/or one or more portionsthereof on one or more displays such as a monitor, for example. Thedisplay(s) can be local and/or remote to a surgical theater. An imagingsystem can include a scope with a camera that views the surgical siteand transmits the view to a display that is viewable by a clinician.Scopes include, but are not limited to, arthroscopes, angioscopes,bronchoscopes, choledochoscopes, colonoscopes, cytoscopes,duodenoscopes, enteroscopes, esophagogastro-duodenoscopes(gastroscopes), endoscopes, laryngoscopes, nasopharyngo-neproscopes,sigmoidoscopes, thoracoscopes, ureteroscopes, and exoscopes. Imagingsystems can be limited by the information that they are able torecognize and/or convey to the clinician(s). For example, certainconcealed structures, physical contours, and/or dimensions within athree-dimensional space may be unrecognizable intraoperatively bycertain imaging systems. Additionally, certain imaging systems may beincapable of communicating and/or conveying certain information to theclinician(s) intraoperatively.

SUMMARY

A powered surgical end-effector is provided. The powered surgicalend-effector comprises a controllable jaw configured to operate on atissue; an updatable memory having stored therein a default actuationalgorithm; and a processor. The processor is configured to: operate in afirst mode at a first time, wherein in the first mode the processor isconfigured to operate an aspect of the controllable jaw according to thedefault actuation algorithm; and receive data at a second time, afterthe first time, that causes the processor to operate in a second mode,wherein in the second mode the processor is configured to operate anaspect of the controllable jaw according to an alternative actuationalgorithm.

A powered surgical end-effector is provided. The powered surgicalend-effector comprises: a controllable jaw configured to operate on atissue; an updatable memory having stored therein a default actuationalgorithm; and a processor. The processor is configured to determinewhether to operate in a first mode or a second mode, wherein in thefirst mode the processor is configured to operate an aspect of the jawaccording to the default actuation algorithm, and wherein in the secondmode the processor is configured to operate an aspect of the jawaccording to an alternative actuation algorithm.

A surgical hub is provided. The surgical hub comprises: a transmitterand a receiver configured to establish a communication pathway betweenthe surgical hub and a powered surgical end-effector; and a processor.The processor is configured to: determine whether communication isavailable with the powered surgical end-effector that is configured tooperate in a first mode or in a second mode, wherein in the first mode,the powered surgical end-effector operates an aspect of a controllablejaw according to a default actuation algorithm stored in the updatablememory of the powered surgical end-effector; receive data from relatedto the powered surgical end-effector via the receiver; determine whetherthe surgical end-effector should operate in the first mode or the secondmode based on the received data; and based on the determination, sendupdated data that causes the powered surgical end-effector to operate inthe second mode, wherein in the second mode, the powered surgicalend-effector operates the aspect of the controllable jaw according to analternative actuation algorithm.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram of a computer-implemented interactive surgicalsystem, in accordance with at least one aspect of the presentdisclosure.

FIG. 2 is a surgical system being used to perform a surgical procedurein an operating room, in accordance with at least one aspect of thepresent disclosure.

FIG. 3 is a surgical hub paired with a visualization system, a roboticsystem, and an intelligent instrument, in accordance with at least oneaspect of the present disclosure.

FIG. 4 illustrates a surgical data network comprising a modularcommunication hub configured to connect modular devices located in oneor more operating theaters of a healthcare facility, or any room in ahealthcare facility specially equipped for surgical operations, to thecloud, in accordance with at least one aspect of the present disclosure.

FIG. 5 illustrates a computer-implemented interactive surgical system,in accordance with at least one aspect of the present disclosure.

FIG. 6 illustrates a surgical hub comprising a plurality of modulescoupled to the modular control tower, in accordance with at least oneaspect of the present disclosure.

FIG. 7 illustrates a logic diagram of a control system of a surgicalinstrument or tool, in accordance with at least one aspect of thepresent disclosure.

FIG. 8 illustrates a surgical instrument or tool comprising a pluralityof motors which can be activated to perform various functions, inaccordance with at least one aspect of the present disclosure.

FIG. 9 illustrates a diagram of a situationally aware surgical system,in accordance with at least one aspect of the present disclosure.

FIG. 10 illustrates a timeline of an illustrative surgical procedure andthe inferences that the surgical hub can make from the data detected ateach step in the surgical procedure, in accordance with at least oneaspect of the present disclosure.

FIG. 11 is a block diagram of the computer-implemented interactivesurgical system, in accordance with at least one aspect of the presentdisclosure.

FIG. 12 is a block diagram which illustrates the functional architectureof the computer-implemented interactive surgical system, in accordancewith at least one aspect of the present disclosure.

FIG. 13 illustrates a block diagram of a computer-implementedinteractive surgical system that is configured to adaptively generatecontrol program updates for modular devices, in accordance with at leastone aspect of the present disclosure.

FIG. 14 illustrates a surgical system that includes a handle having acontroller and a motor, an adapter releasably coupled to the handle, anda loading unit releasably coupled to the adapter, in accordance with atleast one aspect of the present disclosure.

FIG. 15A illustrates an example flow for determining a mode of operationand operating in the determined mode, in accordance with at least oneaspect of the present disclosure.

FIG. 15B illustrates an example flow for changing a mode of operation,in accordance with at least one aspect of the present disclosure.

FIG. 16 is a perspective view of a surgical instrument that has aninterchangeable shaft assembly operably coupled thereto, in accordancewith at least one aspect of this disclosure.

FIG. 17 is an exploded assembly view of a portion of the surgicalinstrument of FIG. 16, in accordance with at least one aspect of thisdisclosure.

FIG. 18 is an exploded assembly view of portions of the interchangeableshaft assembly, in accordance with at least one aspect of thisdisclosure.

FIG. 19 is an exploded view of an end effector of the surgicalinstrument of FIG. 16, in accordance with at least one aspect of thisdisclosure.

FIG. 20A is a block diagram of a control circuit of the surgicalinstrument of FIG. 16 spanning two drawing sheets, in accordance with atleast one aspect of this disclosure.

FIG. 20B is a block diagram of a control circuit of the surgicalinstrument of FIG. 16 spanning two drawing sheets, in accordance with atleast one aspect of this disclosure.

FIG. 21 is a block diagram of the control circuit of the surgicalinstrument of FIG. 16 illustrating interfaces between the handleassembly, the power assembly, and the handle assembly and theinterchangeable shaft assembly, in accordance with at least one aspectof this disclosure.

FIG. 22 depicts an example medical device that can include one or moreaspects of the present disclosure.

FIG. 23 depicts an example end-effector of a medical device surroundingtissue in accordance with one or more aspects of the present disclosure.

FIG. 24 depicts an example end-effector of a medical device compressingtissue in accordance with one or more aspects of the present disclosure.

FIG. 25 depicts example forces exerted by an end-effector of a medicaldevice compressing tissue in accordance with one or more aspects of thepresent disclosure.

FIG. 26 also depicts example forces exerted by an end-effector of amedical device compressing tissue in accordance with one or more aspectsof the present disclosure.

FIG. 27 depicts an example tissue compression sensor system inaccordance with one or more aspects of the present disclosure.

FIG. 28 also depicts an example tissue compression sensor system inaccordance with one or more aspects of the present disclosure.

FIG. 29 also depicts an example tissue compression sensor system inaccordance with one or more aspects of the present disclosure.

FIG. 30 is an example circuit diagram in accordance with one or moreaspects of the present disclosure.

FIG. 31 is also an example circuit diagram in accordance with one ormore aspects of the present disclosure.

FIG. 32 is a diagram of a position sensor comprising a magnetic rotaryabsolute positioning system, in accordance with at least one aspect ofthis disclosure.

FIG. 33 is a section view of an end effector of a surgical instrumentshowing a firing member stroke relative to tissue grasped with the endeffector, in accordance with at least one aspect of this disclosure.

FIG. 34 illustrates a block diagram of a surgical system configured tocontrol a surgical function, in accordance with at least one aspect ofthe present disclosure.

FIG. 35 illustrates a block diagram of a situationally aware surgicalsystem configured to control a surgical function, in accordance with atleast one aspect of the present disclosure.

FIG. 36 is a logic flow diagram depicting a situational awareness basedalgorithm for controlling a surgical function, in accordance with atleast one aspect of the present disclosure.

FIG. 37 illustrates a logic flow diagram of a process for controlling asurgical instrument according to the physiological type of the clampedtissue, in accordance with at least one aspect of the presentdisclosure.

FIG. 38 is a logic flow diagram depicting a process of a control programor a logic configuration for adjusting a closure rate algorithm, inaccordance with at least one aspect of the present disclosure.

FIG. 39 illustrates a logic flow diagram of a process depicting acontrol program of a logic configuration for identifying irregularitiesin tissue distribution within an end effector of a surgical instrument,in accordance with at least one aspect of the present disclosure.

FIG. 40 illustrates a logic flow diagram of a process depicting acontrol program or a logic configuration for properly positioning apreviously stapled tissue within an end effector, in accordance with atleast one aspect of the present disclosure.

FIG. 41 illustrates a logic flow diagram of a process for updating thecontrol program of a modular device, in accordance with at least oneaspect of the present disclosure.

FIG. 42 illustrates a diagram of an analytics system pushing an updateto a modular device through a surgical hub, in accordance with at leastone aspect of the present disclosure.

FIG. 43 illustrates a diagram of a computer-implemented interactivesurgical system that is configured to adaptively generate controlprogram updates for surgical hubs, in accordance with at least oneaspect of the present disclosure.

FIG. 44 illustrates a logic flow diagram of a process for updating thecontrol program of a surgical hub, in accordance with at least oneaspect of the present disclosure.

FIG. 45 illustrates a logic flow diagram of a process for updating thedata analysis algorithm of a control program of a surgical hub, inaccordance with at least one aspect of the present disclosure.

FIG. 46 illustrates a system for communication between a surgicalinstrument, a surgical hub, and a cloud computing system, in accordancewith at least one aspect of the present disclosure.

FIG. 47 illustrates a logic flow diagram of a process for updating thealgorithm of a surgical instrument, in accordance with at least oneaspect of the present disclosure.

FIG. 48 illustrates another logic flow diagram of a process for updatingan algorithm of a surgical instrument, in accordance with at least oneaspect of the present disclosure.

FIG. 49 illustrates another logic flow diagram of a process for updatingan algorithm of a surgical instrument, in accordance with at least oneaspect of the present disclosure.

FIG. 50 illustrates a logic flow diagram of a process for a surgical hubupdating an algorithm of a surgical instrument, in accordance with atleast one aspect of the present disclosure.

DETAILED DESCRIPTION

Applicant of the present application owns the following U.S. patentapplications, filed contemporaneously, each of which is hereinincorporated by reference in its entirety:

-   U.S. patent application Ser. No. 16/209,423 (Attorney Docket No.    END8538USNP), entitled “METHOD OF COMPRESSING TISSUE WITHIN A    STAPLING DEVICE AND SIMULTANEOUSLY DISPLAYING THE LOCATION OF THE    TISSUE WITHIN THE JAWS,” filed on Dec. 4, 2018, now U.S. Patent    Application Publication No. 2019/0200981; and-   U.S. patent application Ser. No. 15/940,636 (Attorney Docket No.    END8506USNP), entitled “ADAPTIVE CONTROL PROGRAM UPDATES FOR    SURGICAL DEVICES,” filed Mar. 29, 2018, now U.S. Patent Application    Publication No. 2019/0206003.

Referring to FIG. 1, a computer-implemented interactive surgical system100 may include one or more surgical systems 102 and a cloud-basedsystem (e.g., the cloud 104 that may include a remote server 113 coupledto a storage device 105). Each surgical system 102 may include at leastone surgical hub 106 in communication with the cloud 104 that mayinclude a remote server 113. In one example, as illustrated in FIG. 1,the surgical system 102 includes a visualization system 108, a roboticsystem 110, and a handheld intelligent surgical instrument 112, whichare configured to communicate with one another and/or the hub 106. Insome aspects, a surgical system 102 may include an M number of hubs 106,an N number of visualization systems 108, an O number of robotic systems110, and a P number of handheld intelligent surgical instruments 112,where M, N, O, and P may be integers greater than or equal to one.

In various aspects, the visualization system 108 may include one or moreimaging sensors, one or more image-processing units, one or more storagearrays, and one or more displays that are strategically arranged withrespect to the sterile field, as illustrated in FIG. 2. In one aspect,the visualization system 108 may include an interface for HL7, PACS, andEMR. Various components of the visualization system 108 are describedunder the heading “Advanced Imaging Acquisition Module” in U.S. PatentApplication Publication No. US 2019-0200844 A1 (U.S. patent applicationSer. No. 16/209,385), titled METHOD OF HUB COMMUNICATION, PROCESSING,STORAGE AND DISPLAY, filed Dec. 4, 2018, the disclosure of which isherein incorporated by reference in its entirety.

As illustrated in FIG. 2, a primary display 119 is positioned in thesterile field to be visible to an operator at the operating table 114.In addition, a visualization tower 111 is positioned outside the sterilefield. The visualization tower 111 may include a first non-steriledisplay 107 and a second non-sterile display 109, which face away fromeach other. The visualization system 108, guided by the hub 106, isconfigured to utilize the displays 107, 109, and 119 to coordinateinformation flow to operators inside and outside the sterile field. Forexample, the hub 106 may cause the visualization system 108 to display asnapshot of a surgical site, as recorded by an imaging device 124, on anon-sterile display 107 or 109, while maintaining a live feed of thesurgical site on the primary display 119. The snapshot on thenon-sterile display 107 or 109 can permit a non-sterile operator toperform a diagnostic step relevant to the surgical procedure, forexample.

In one aspect, the hub 106 may also be configured to route a diagnosticinput or feedback entered by a non-sterile operator at the visualizationtower 111 to the primary display 119 within the sterile field, where itcan be viewed by a sterile operator at the operating table. In oneexample, the input can be in the form of a modification to the snapshotdisplayed on the non-sterile display 107 or 109, which can be routed tothe primary display 119 by the hub 106.

Referring to FIG. 2, a surgical instrument 112 is being used in thesurgical procedure as part of the surgical system 102. The hub 106 mayalso be configured to coordinate information flow to a display of thesurgical instrument 112. For example, in U.S. Patent ApplicationPublication No. US 2019-0200844 A1 (U.S. patent application Ser. No.16/209,385), titled METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE ANDDISPLAY, filed Dec. 4, 2018, the disclosure of which is hereinincorporated by reference in its entirety. A diagnostic input orfeedback entered by a non-sterile operator at the visualization tower111 can be routed by the hub 106 to the surgical instrument display 115within the sterile field, where it can be viewed by the operator of thesurgical instrument 112. Example surgical instruments that are suitablefor use with the surgical system 102 are described under the heading“Surgical Instrument Hardware” and in U.S. Patent ApplicationPublication No. US 2019-0200844 A1 (U.S. patent application Ser. No.16/209,385), titled METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE ANDDISPLAY, filed Dec. 4, 2018, the disclosure of which is hereinincorporated by reference in its entirety, for example.

FIG. 2 depicts an example of a surgical system 102 being used to performa surgical procedure on a patient who is lying down on an operatingtable 114 in a surgical operating room 116. A robotic system 110 may beused in the surgical procedure as a part of the surgical system 102. Therobotic system 110 may include a surgeon's console 118, a patient sidecart 120 (surgical robot), and a surgical robotic hub 122. The patientside cart 120 can manipulate at least one removably coupled surgicaltool 117 through a minimally invasive incision in the body of thepatient while the surgeon views the surgical site through the surgeon'sconsole 118. An image of the surgical site can be obtained by a medicalimaging device 124, which can be manipulated by the patient side cart120 to orient the imaging device 124. The robotic hub 122 can be used toprocess the images of the surgical site for subsequent display to thesurgeon through the surgeon's console 118.

Other types of robotic systems can be readily adapted for use with thesurgical system 102. Various examples of robotic systems and surgicaltools that are suitable for use with the present disclosure aredescribed in U.S. Patent Application Publication No. US 2019-0201137 A1(U.S. patent application Ser. No. 16/209,407), titled METHOD OF ROBOTICHUB COMMUNICATION, DETECTION, AND CONTROL, filed Dec. 4, 2018, thedisclosure of which is herein incorporated by reference in its entirety.

Various examples of cloud-based analytics that are performed by thecloud 104, and are suitable for use with the present disclosure, aredescribed in U.S. Patent Application Publication No. US 2019-0206569 A1(U.S. patent application Ser. No. 16/209,403), titled METHOD OF CLOUDBASED DATA ANALYTICS FOR USE WITH THE HUB, filed Dec. 4, 2018, thedisclosure of which is herein incorporated by reference in its entirety.

In various aspects, the imaging device 124 may include at least oneimage sensor and one or more optical components. Suitable image sensorsmay include, but are not limited to, Charge-Coupled Device (CCD) sensorsand Complementary Metal-Oxide Semiconductor (CMOS) sensors.

The optical components of the imaging device 124 may include one or moreillumination sources and/or one or more lenses. The one or moreillumination sources may be directed to illuminate portions of thesurgical field. The one or more image sensors may receive lightreflected or refracted from the surgical field, including lightreflected or refracted from tissue and/or surgical instruments.

The one or more illumination sources may be configured to radiateelectromagnetic energy in the visible spectrum as well as the invisiblespectrum. The visible spectrum, sometimes referred to as the opticalspectrum or luminous spectrum, is that portion of the electromagneticspectrum that is visible to (i.e., can be detected by) the human eye andmay be referred to as visible light or simply light. A typical human eyewill respond to wavelengths in air that are from about 380 nm to about750 nm.

The invisible spectrum (e.g., the non-luminous spectrum) is that portionof the electromagnetic spectrum that lies below and above the visiblespectrum (i.e., wavelengths below about 380 nm and above about 750 nm).The invisible spectrum is not detectable by the human eye. Wavelengthsgreater than about 750 nm are longer than the red visible spectrum, andthey become invisible infrared (IR), microwave, and radioelectromagnetic radiation. Wavelengths less than about 380 nm areshorter than the violet spectrum, and they become invisible ultraviolet,x-ray, and gamma ray electromagnetic radiation.

In various aspects, the imaging device 124 is configured for use in aminimally invasive procedure. Examples of imaging devices suitable foruse with the present disclosure include, but not limited to, anarthroscope, angioscope, bronchoscope, choledochoscope, colonoscope,cytoscope, duodenoscope, enteroscope, esophagogastro-duodenoscope(gastroscope), endoscope, laryngoscope, nasopharyngo-neproscope,sigmoidoscope, thoracoscope, and ureteroscope.

The imaging device may employ multi-spectrum monitoring to discriminatetopography and underlying structures. A multi-spectral image is one thatcaptures image data within specific wavelength ranges across theelectromagnetic spectrum. The wavelengths may be separated by filters orby the use of instruments that are sensitive to particular wavelengths,including light from frequencies beyond the visible light range, e.g.,IR and ultraviolet. Spectral imaging can allow extraction of additionalinformation the human eye fails to capture with its receptors for red,green, and blue. The use of multi-spectral imaging is described ingreater detail under the heading “Advanced Imaging Acquisition Module”in U.S. Patent Application Publication No. US 2019-0200844 A1 (U.S.patent application Ser. No. 16/209,385), titled METHOD OF HUBCOMMUNICATION, PROCESSING, STORAGE AND DISPLAY, filed Dec. 4, 2018, thedisclosure of which is herein incorporated by reference in its entirety.Multi-spectrum monitoring can be a useful tool in relocating a surgicalfield after a surgical task is completed to perform one or more of thepreviously described tests on the treated tissue. It is axiomatic thatstrict sterilization of the operating room and surgical equipment isrequired during any surgery. The strict hygiene and sterilizationconditions required in a “surgical theater,” i.e., an operating ortreatment room, necessitate the highest possible sterility of allmedical devices and equipment. Part of that sterilization process is theneed to sterilize anything that comes in contact with the patient orpenetrates the sterile field, including the imaging device 124 and itsattachments and components. It will be appreciated that the sterilefield may be considered a specified area, such as within a tray or on asterile towel, that is considered free of microorganisms, or the sterilefield may be considered an area, immediately around a patient, who hasbeen prepared for a surgical procedure. The sterile field may includethe scrubbed team members, who are properly attired, and all furnitureand fixtures in the area.

Referring now to FIG. 3, a hub 106 is depicted in communication with avisualization system 108, a robotic system 110, and a handheldintelligent surgical instrument 112. The hub 106 includes a hub display135, an imaging module 138, a generator module 140, a communicationmodule 130, a processor module 132, a storage array 134, and anoperating-room mapping module 133. In certain aspects, as illustrated inFIG. 3, the hub 106 further includes a smoke evacuation module 126and/or a suction/irrigation module 128. During a surgical procedure,energy application to tissue, for sealing and/or cutting, is generallyassociated with smoke evacuation, suction of excess fluid, and/orirrigation of the tissue. Fluid, power, and/or data lines from differentsources are often entangled during the surgical procedure. Valuable timecan be lost addressing this issue during a surgical procedure.Detangling the lines may necessitate disconnecting the lines from theirrespective modules, which may require resetting the modules. The hubmodular enclosure 136 offers a unified environment for managing thepower, data, and fluid lines, which reduces the frequency ofentanglement between such lines. Aspects of the present disclosurepresent a surgical hub for use in a surgical procedure that involvesenergy application to tissue at a surgical site. The surgical hubincludes a hub enclosure and a combo generator module slidablyreceivable in a docking station of the hub enclosure. The dockingstation includes data and power contacts. The combo generator moduleincludes two or more of an ultrasonic energy generator component, abipolar RF energy generator component, and a monopolar RF energygenerator component that are housed in a single unit. In one aspect, thecombo generator module also includes a smoke evacuation component, atleast one energy delivery cable for connecting the combo generatormodule to a surgical instrument, at least one smoke evacuation componentconfigured to evacuate smoke, fluid, and/or particulates generated bythe application of therapeutic energy to the tissue, and a fluid lineextending from the remote surgical site to the smoke evacuationcomponent. In one aspect, the fluid line is a first fluid line and asecond fluid line extends from the remote surgical site to a suction andirrigation module slidably received in the hub enclosure. In one aspect,the hub enclosure comprises a fluid interface. Certain surgicalprocedures may require the application of more than one energy type tothe tissue. One energy type may be more beneficial for cutting thetissue, while another different energy type may be more beneficial forsealing the tissue. For example, a bipolar generator can be used to sealthe tissue while an ultrasonic generator can be used to cut the sealedtissue. Aspects of the present disclosure present a solution where a hubmodular enclosure 136 is configured to accommodate different generators,and facilitate an interactive communication therebetween. One of theadvantages of the hub modular enclosure 136 is enabling the quickremoval and/or replacement of various modules. Aspects of the presentdisclosure present a modular surgical enclosure for use in a surgicalprocedure that involves energy application to tissue. The modularsurgical enclosure includes a first energy-generator module, configuredto generate a first energy for application to the tissue, and a firstdocking station comprising a first docking port that includes first dataand power contacts, wherein the first energy-generator module isslidably movable into an electrical engagement with the power and datacontacts and wherein the first energy-generator module is slidablymovable out of the electrical engagement with the first power and datacontacts. Further to the above, the modular surgical enclosure alsoincludes a second energy-generator module configured to generate asecond energy, different than the first energy, for application to thetissue, and a second docking station comprising a second docking portthat includes second data and power contacts, wherein the secondenergy-generator module is slidably movable into an electricalengagement with the power and data contacts, and wherein the secondenergy-generator module is slidably movable out of the electricalengagement with the second power and data contacts. In addition, themodular surgical enclosure also includes a communication bus between thefirst docking port and the second docking port, configured to facilitatecommunication between the first energy-generator module and the secondenergy-generator module. Referring to FIG. 3, aspects of the presentdisclosure are presented for a hub modular enclosure 136 that allows themodular integration of a generator module 140, a smoke evacuation module126, and a suction/irrigation module 128. The hub modular enclosure 136further facilitates interactive communication between the modules 140,126, 128. The generator module 140 can be a generator module withintegrated monopolar, bipolar, and ultrasonic components supported in asingle housing unit slidably insertable into the hub modular enclosure136. The generator module 140 can be configured to connect to amonopolar device 142, a bipolar device 144, and an ultrasonic device146. Alternatively, the generator module 140 may comprise a series ofmonopolar, bipolar, and/or ultrasonic generator modules that interactthrough the hub modular enclosure 136. The hub modular enclosure 136 canbe configured to facilitate the insertion of multiple generators andinteractive communication between the generators docked into the hubmodular enclosure 136 so that the generators would act as a singlegenerator.

FIG. 4 illustrates a surgical data network 201 comprising a modularcommunication hub 203 configured to connect modular devices located inone or more operating theaters of a healthcare facility, or any room ina healthcare facility specially equipped for surgical operations, to acloud-based system (e.g., the cloud 204 that may include a remote server213 coupled to a storage device 205). In one aspect, the modularcommunication hub 203 comprises a network hub 207 and/or a networkswitch 209 in communication with a network router. The modularcommunication hub 203 also can be coupled to a local computer system 210to provide local computer processing and data manipulation. The surgicaldata network 201 may be configured as passive, intelligent, orswitching. A passive surgical data network serves as a conduit for thedata, enabling it to go from one device (or segment) to another and tothe cloud computing resources. An intelligent surgical data networkincludes additional features to enable the traffic passing through thesurgical data network to be monitored and to configure each port in thenetwork hub 207 or network switch 209. An intelligent surgical datanetwork may be referred to as a manageable hub or switch. A switchinghub reads the destination address of each packet and then forwards thepacket to the correct port.

Modular devices 1 a-1 n located in the operating theater may be coupledto the modular communication hub 203. The network hub 207 and/or thenetwork switch 209 may be coupled to a network router 211 to connect thedevices 1 a-1 n to the cloud 204 or the local computer system 210. Dataassociated with the devices 1 a-1 n may be transferred to cloud-basedcomputers via the router for remote data processing and manipulation.Data associated with the devices 1 a-1 n may also be transferred to thelocal computer system 210 for local data processing and manipulation.Modular devices 2 a-2 m located in the same operating theater also maybe coupled to a network switch 209. The network switch 209 may becoupled to the network hub 207 and/or the network router 211 to connectto the devices 2 a-2 m to the cloud 204. Data associated with thedevices 2 a-2 n may be transferred to the cloud 204 via the networkrouter 211 for data processing and manipulation. Data associated withthe devices 2 a-2 m may also be transferred to the local computer system210 for local data processing and manipulation.

It will be appreciated that the surgical data network 201 may beexpanded by interconnecting multiple network hubs 207 and/or multiplenetwork switches 209 with multiple network routers 211. The modularcommunication hub 203 may be contained in a modular control towerconfigured to receive multiple devices 1 a-1 n/2 a-2 m. The localcomputer system 210 also may be contained in a modular control tower.The modular communication hub 203 is connected to a display 212 todisplay images obtained by some of the devices 1 a-1 n/2 a-2 m, forexample during surgical procedures. In various aspects, the devices 1a-1 n/2 a-2 m may include, for example, various modules such as animaging module 138 coupled to an endoscope, a generator module 140coupled to an energy-based surgical device, a smoke evacuation module126, a suction/irrigation module 128, a communication module 130, aprocessor module 132, a storage array 134, a surgical device coupled toa display, and/or a non-contact sensor module, among other modulardevices that may be connected to the modular communication hub 203 ofthe surgical data network 201.

In one aspect, the surgical data network 201 may comprise a combinationof network hub(s), network switch(es), and network router(s) connectingthe devices 1 a-1 n/2 a-2 m to the cloud. Any one of or all of thedevices 1 a-1 n/2 a-2 m coupled to the network hub or network switch maycollect data in real time and transfer the data to cloud computers fordata processing and manipulation. It will be appreciated that cloudcomputing relies on sharing computing resources rather than having localservers or personal devices to handle software applications. The word“cloud” may be used as a metaphor for “the Internet,” although the termis not limited as such. Accordingly, the term “cloud computing” may beused herein to refer to “a type of Internet-based computing,” wheredifferent services—such as servers, storage, and applications—aredelivered to the modular communication hub 203 and/or computer system210 located in the surgical theater (e.g., a fixed, mobile, temporary,or field operating room or space) and to devices connected to themodular communication hub 203 and/or computer system 210 through theInternet. The cloud infrastructure may be maintained by a cloud serviceprovider. In this context, the cloud service provider may be the entitythat coordinates the usage and control of the devices 1 a-1 n/2 a-2 mlocated in one or more operating theaters. The cloud computing servicescan perform a large number of calculations based on the data gathered bysmart surgical instruments, robots, and other computerized deviceslocated in the operating theater. The hub hardware enables multipledevices or connections to be connected to a computer that communicateswith the cloud computing resources and storage.

Applying cloud computer data processing techniques on the data collectedby the devices 1 a-1 n/2 a-2 m, the surgical data network can provideimproved surgical outcomes, reduced costs, and improved patientsatisfaction. At least some of the devices 1 a-1 n/2 a-2 m may beemployed to view tissue states to assess leaks or perfusion of sealedtissue after a tissue sealing and cutting procedure. At least some ofthe devices 1 a-1 n/2 a-2 m may be employed to identify pathology, suchas the effects of diseases, using the cloud-based computing to examinedata including images of samples of body tissue for diagnostic purposes.This may include localization and margin confirmation of tissue andphenotypes. At least some of the devices 1 a-1 n/2 a-2 m may be employedto identify anatomical structures of the body using a variety of sensorsintegrated with imaging devices and techniques such as overlaying imagescaptured by multiple imaging devices. The data gathered by the devices 1a-1 n/2 a-2 m, including image data, may be transferred to the cloud 204or the local computer system 210 or both for data processing andmanipulation including image processing and manipulation. The data maybe analyzed to improve surgical procedure outcomes by determining iffurther treatment, such as the application of endoscopic intervention,emerging technologies, a targeted radiation, targeted intervention, andprecise robotics to tissue-specific sites and conditions, may bepursued. Such data analysis may further employ outcome analyticsprocessing, and using standardized approaches may provide beneficialfeedback to either confirm surgical treatments and the behavior of thesurgeon or suggest modifications to surgical treatments and the behaviorof the surgeon.

The operating theater devices 1 a-1 n may be connected to the modularcommunication hub 203 over a wired channel or a wireless channeldepending on the configuration of the devices 1 a-1 n to a network hub.The network hub 207 may be implemented, in one aspect, as a localnetwork broadcast device that works on the physical layer of the OpenSystem Interconnection (OSI) model. The network hub may provideconnectivity to the devices 1 a-1 n located in the same operatingtheater network. The network hub 207 may collect data in the form ofpackets and sends them to the router in half duplex mode. The networkhub 207 may not store any media access control/Internet Protocol(MAC/IP) to transfer the device data. Only one of the devices 1 a-1 ncan send data at a time through the network hub 207. The network hub 207may not have routing tables or intelligence regarding where to sendinformation and broadcasts all network data across each connection andto a remote server 213 (FIG. 4) over the cloud 204. The network hub 207can detect basic network errors such as collisions, but having allinformation broadcast to multiple ports can be a security risk and causebottlenecks.

The operating theater devices 2 a-2 m may be connected to a networkswitch 209 over a wired channel or a wireless channel. The networkswitch 209 works in the data link layer of the OSI model. The networkswitch 209 may be a multicast device for connecting the devices 2 a-2 mlocated in the same operating theater to the network. The network switch209 may send data in the form of frames to the network router 211 andworks in full duplex mode. Multiple devices 2 a-2 m can send data at thesame time through the network switch 209. The network switch 209 storesand uses MAC addresses of the devices 2 a-2 m to transfer data.

The network hub 207 and/or the network switch 209 may be coupled to thenetwork router 211 for connection to the cloud 204. The network router211 works in the network layer of the OSI model. The network router 211creates a route for transmitting data packets received from the networkhub 207 and/or network switch 211 to cloud-based computer resources forfurther processing and manipulation of the data collected by any one ofor all the devices 1 a-1 n/2 a-2 m. The network router 211 may beemployed to connect two or more different networks located in differentlocations, such as, for example, different operating theaters of thesame healthcare facility or different networks located in differentoperating theaters of different healthcare facilities. The networkrouter 211 may send data in the form of packets to the cloud 204 andworks in full duplex mode. Multiple devices can send data at the sametime. The network router 211 uses IP addresses to transfer data.

In an example, the network hub 207 may be implemented as a USB hub,which allows multiple USB devices to be connected to a host computer.The USB hub may expand a single USB port into several tiers so thatthere are more ports available to connect devices to the host systemcomputer. The network hub 207 may include wired or wireless capabilitiesto receive information over a wired channel or a wireless channel. Inone aspect, a wireless USB short-range, high-bandwidth wireless radiocommunication protocol may be employed for communication between thedevices 1 a-1 n and devices 2 a-2 m located in the operating theater.

In examples, the operating theater devices 1 a-1 n/2 a-2 m maycommunicate to the modular communication hub 203 via Bluetooth wirelesstechnology standard for exchanging data over short distances (usingshort-wavelength UHF radio waves in the ISM band from 2.4 to 2.485 GHz)from fixed and mobile devices and building personal area networks(PANs). The the operating theater devices 1 a-1 n/2 a-2 m maycommunicate to the modular communication hub 203 via a number ofwireless or wired communication standards or protocols, including butnot limited to Wi-Fi (IEEE 802.11 family), WiMAX (IEEE 802.16 family),IEEE 802.20, new radio (NR), long-term evolution (LTE), and Ev-DO,HSPA+, HSDPA+, HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and Ethernetderivatives thereof, as well as any other wireless and wired protocolsthat are designated as 3G, 4G, 5G, and beyond. The computing module mayinclude a plurality of communication modules. For instance, a firstcommunication module may be dedicated to shorter-range wirelesscommunications such as Wi-Fi and Bluetooth, and a second communicationmodule may be dedicated to longer-range wireless communications such asGPS, EDGE, GPRS, CDMA, WiMAX, LTE, Ev-DO, and others.

The modular communication hub 203 may serve as a central connection forone or all of the operating theater devices 1 a-1 n/2 a-2 m and mayhandle a data type known as frames. Frames may carry the data generatedby the devices 1 a-1 n/2 a-2 m. When a frame is received by the modularcommunication hub 203, it is amplified and transmitted to the networkrouter 211, which transfers the data to the cloud computing resources byusing a number of wireless or wired communication standards orprotocols, as described herein.

The modular communication hub 203 can be used as a standalone device orbe connected to compatible network hubs and network switches to form alarger network. The modular communication hub 203 can be generally easyto install, configure, and maintain, making it a good option fornetworking the operating theater devices 1 a-1 n/2 a-2 m.

FIG. 5 illustrates a computer-implemented interactive surgical system200. The computer-implemented interactive surgical system 200 is similarin many respects to the computer-implemented interactive surgical system100. For example, the computer-implemented interactive surgical system200 includes one or more surgical systems 202, which are similar in manyrespects to the surgical systems 102. Each surgical system 202 includesat least one surgical hub 206 in communication with a cloud 204 that mayinclude a remote server 213. In one aspect, the computer-implementedinteractive surgical system 200 comprises a modular control tower 236connected to multiple operating theater devices such as, for example,intelligent surgical instruments, robots, and other computerized deviceslocated in the operating theater. As shown m FIG. 6, the modular controltower 236 comprises a modular communication hub 203 coupled to acomputer system 210.

As illustrated in the example of FIG. 5, the modular control tower 236may be coupled to an imaging module 238 that may be coupled to anendoscope 239, a generator module 240 that may be coupled to an energydevice 241, a smoke evacuator module 226, a suction/irrigation module228, a communication module 230, a processor module 232, a storage array234, a smart device/instrument 235 optionally coupled to a display 237,and a non-contact sensor module 242. The operating theater devices maybe coupled to cloud computing resources and data storage via the modularcontrol tower 236. A robot hub 222 also may be connected to the modularcontrol tower 236 and to the cloud computing resources. Thedevices/instruments 235, visualization systems 208, among others, may becoupled to the modular control tower 236 via wired or wirelesscommunication standards or protocols, as described herein. The modularcontrol tower 236 may be coupled to a hub display 215 (e.g., monitor,screen) to display and overlay images received from the imaging module,device/instrument display, and/or other visualization systems 208. Thehub display also may display data received from devices connected to themodular control tower in conjunction with images and overlaid images.

FIG. 6 illustrates a surgical hub 206 comprising a plurality of modulescoupled to the modular control tower 236. The modular control tower 236may comprise a modular communication hub 203, e.g., a networkconnectivity device, and a computer system 210 to provide localprocessing, visualization, and imaging, for example. As shown in FIG. 6,the modular communication hub 203 may be connected in a tieredconfiguration to expand the number of modules (e.g., devices) that maybe connected to the modular communication hub 203 and transfer dataassociated with the modules to the computer system 210, cloud computingresources, or both. As shown in FIG. 6, each of the networkhubs/switches in the modular communication hub 203 may include threedownstream ports and one upstream port. The upstream network hub/switchmay be connected to a processor to provide a communication connection tothe cloud computing resources and a local display 217. Communication tothe cloud 204 may be made either through a wired or a wirelesscommunication channel.

The surgical hub 206 may employ a non-contact sensor module 242 tomeasure the dimensions of the operating theater and generate a map ofthe surgical theater using either ultrasonic or laser-type non-contactmeasurement devices. An ultrasound-based non-contact sensor module mayscan the operating theater by transmitting a burst of ultrasound andreceiving the echo when it bounces off the perimeter walls of anoperating theater as described under the heading “Surgical Hub SpatialAwareness Within an Operating Room” in .S. Patent ApplicationPublication No. US 2019-0200844 A1 (U.S. patent application Ser. No.16/209,385), titled METHOD OF HUB COMMUNICATION, PROCESSING, STORAGE ANDDISPLAY, filed Dec. 4, 2018, which is herein incorporated by referencein its entirety, in which the sensor module is configured to determinethe size of the operating theater and to adjust Bluetooth-pairingdistance limits. A laser-based non-contact sensor module may scan theoperating theater by transmitting laser light pulses, receiving laserlight pulses that bounce off the perimeter walls of the operatingtheater, and comparing the phase of the transmitted pulse to thereceived pulse to determine the size of the operating theater and toadjust Bluetooth pairing distance limits, for example.

The computer system 210 may comprise a processor 244 and a networkinterface 245. The processor 244 can be coupled to a communicationmodule 247, storage 248, memory 249, non-volatile memory 250, andinput/output interface 251 via a system bus. The system bus can be anyof several types of bus structure(s) including the memory bus or memorycontroller, a peripheral bus or external bus, and/or a local bus usingany variety of available bus architectures including, but not limitedto, 9-bit bus, Industrial Standard Architecture (ISA), Micro-ChannelArchitecture (MSA). Extended ISA (EISA), Intelligent Drive Electronics(IDE), VESA Local Bus (VLB), Peripheral Component Interconnect (PCI),USB, Advanced Graphics Port (AGP), Personal Computer Memory CardInternational Association bus (PCMCIA), Small Computer Systems Interface(SCSI), or any other proprietary bus.

The processor 244 may be any single-core or multicore processor such asthose known under the trade name ARM Cortex by Texas Instruments. In oneaspect, the processor may be an LM4F230H5QR ARM Cortex-M4F ProcessorCore, available from Texas Instruments, for example, comprising anon-chip memory of 256 KB single-cycle flash memory, or othernon-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle serial random accessmemory (SRAM), an internal read-only memory (ROM) loaded withStellarisWare® software, a 2 KB electrically erasable programmableread-only memory (EEPROM), and/or one or more pulse width modulation(PWM) modules, one or more quadrature encoder inputs (QEI) analogs, oneor more 12-bit analog-to-digital converters (ADCs) with 12 analog inputchannels, details of which are available for the product datasheet.

In one aspect, the processor 244 may comprise a safety controllercomprising two controller-based families such as TMS570 and RM4x, knownunder the trade name Hercules ARM Cortex R4, also by Texas Instruments.The safety controller may be configured specifically for IEC 61508 andISO 26262 safety critical applications, among others, to provideadvanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The system memory may include volatile memory and non-volatile memory.The basic input/output system (BIOS), containing the basic routines totransfer information between elements within the computer system, suchas during start-up, is stored in non-volatile memory. For example, thenon-volatile memory can include ROM, programmable ROM (PROM),electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatilememory includes random-access memory (RAM), which acts as external cachememory. Moreover, RAM is available in many forms such as SRAM, dynamicRAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDRSDRAM), enhanced SDRAM (ESDRAM), Synchlink DRAM (SLDRAM), and directRambus RAM (DRRAM).

The computer system 210 also may include removable/non-removable,volatile/non-volatile computer storage media, such as for example diskstorage. The disk storage can include, but is not limited to, deviceslike a magnetic disk drive, floppy disk drive, tape drive, Jaz drive,Zip drive, LS-60 drive, flash memory card, or memory stick. In addition,the disk storage can include storage media separately or in combinationwith other storage media including, but not limited to, an optical discdrive such as a compact disc ROM device (CD-ROM), compact discrecordable drive (CD-R Drive), compact disc rewritable drive (CD-RWDrive), or a digital versatile disc ROM drive (DVD-ROM). To facilitatethe connection of the disk storage devices to the system bus, aremovable or non-removable interface may be employed.

It is to be appreciated that the computer system 210 may includesoftware that acts as an intermediary between users and the basiccomputer resources described in a suitable operating environment. Suchsoftware may include an operating system. The operating system, whichcan be stored on the disk storage, may act to control and allocateresources of the computer system. System applications may take advantageof the management of resources by the operating system through programmodules and program data stored either in the system memory or on thedisk storage. It is to be appreciated that various components describedherein can be implemented with various operating systems or combinationsof operating systems.

A user may enter commands or information into the computer system 210through input device(s) coupled to the I/O interface 251. The inputdevices may include, but are not limited to, a pointing device such as amouse, trackball, stylus, touch pad, keyboard, microphone, joystick,game pad, satellite dish, scanner, TV tuner card, digital camera,digital video camera, web camera, and the like. These and other inputdevices connect to the processor through the system bus via interfaceport(s). The interface port(s) include, for example, a serial port, aparallel port, a game port, and a USB. The output device(s) use some ofthe same types of ports as input device(s). Thus, for example, a USBport may be used to provide input to the computer system and to outputinformation from the computer system to an output device. An outputadapter may be provided to illustrate that there can be some outputdevices like monitors, displays, speakers, and printers, among otheroutput devices that may require special adapters. The output adaptersmay include, by way of illustration and not limitation, video and soundcards that provide a means of connection between the output device andthe system bus. It should be noted that other devices and/or systems ofdevices, such as remote computer(s), may provide both input and outputcapabilities.

The computer system 210 can operate in a networked environment usinglogical connections to one or more remote computers, such as cloudcomputer(s), or local computers. The remote cloud computer(s) can be apersonal computer, server, router, network PC, workstation,microprocessor-based appliance, peer device, or other common networknode, and the like, and typically includes many or all of the elementsdescribed relative to the computer system. For purposes of brevity, onlya memory storage device is illustrated with the remote computer(s). Theremote computer(s) may be logically connected to the computer systemthrough a network interface and then physically connected via acommunication connection. The network interface may encompasscommunication networks such as local area networks (LANs) and wide areanetworks (WANs). LAN technologies may include Fiber Distributed DataInterface (FDDI), Copper Distributed Data Interface (CDDI),Ethernet/IEEE 802.3, Token Ring/IEEE 802.5 and the like. WANtechnologies may include, but are not limited to, point-to-point links,circuit-switching networks like Integrated Services Digital Networks(ISDN) and variations thereon, packet-switching networks, and DigitalSubscriber Lines (DSL).

In various aspects, the computer system 210 of FIG. 6, the imagingmodule 238 and/or visualization system 208, and/or the processor module232 of FIGS. 5-6, may comprise an image processor, image-processingengine, media processor, or any specialized digital signal processor(DSP) used for the processing of digital images. The image processor mayemploy parallel computing with single instruction, multiple data (SIMD)or multiple instruction, multiple data (MIMD) technologies to increasespeed and efficiency. The digital image-processing engine can perform arange of tasks. The image processor may be a system on a chip withmulticore processor architecture.

The communication connection(s) may refer to the hardware/softwareemployed to connect the network interface to the bus. While thecommunication connection is shown for illustrative clarity inside thecomputer system, it can also be external to the computer system 210. Thehardware/software necessary for connection to the network interface mayinclude, for illustrative purposes only, internal and externaltechnologies such as modems, including regular telephone-grade modems,cable modems, and DSL modems, ISDN adapters, and Ethernet cards.

FIG. 7 illustrates a logic diagram of a control system 470 of a surgicalinstrument or tool in accordance with one or more aspects of the presentdisclosure. The system 470 may comprise a control circuit. The controlcircuit may include a microcontroller 461 comprising a processor 462 anda memory 468. One or more of sensors 472, 474, 476, for example, providereal-time feedback to the processor 462. A motor 482, driven by a motordriver 492, operably couples a longitudinally movable displacementmember to drive the I-beam knife element. A tracking system 480 may beconfigured to determine the position of the longitudinally movabledisplacement member. The position information may be provided to theprocessor 462, which can be programmed or configured to determine theposition of the longitudinally movable drive member as well as theposition of a firing member, firing bar, and I-beam knife element.Additional motors may be provided at the tool driver interface tocontrol I-beam firing, closure tube travel, shaft rotation, andarticulation. A display 473 may display a variety of operatingconditions of the instruments and may include touch screen functionalityfor data input. Information displayed on the display 473 may be overlaidwith images acquired via endoscopic imaging modules.

In one aspect, the microcontroller 461 may be any single-core ormulticore processor such as those known under the trade name ARM Cortexby Texas Instruments. In one aspect, the main microcontroller 461 may bean LM4F230H5QR ARM Cortex-M4F Processor Core, available from TexasInstruments, for example, comprising an on-chip memory of 256 KBsingle-cycle flash memory, or other non-volatile memory, up to 40 MHz, aprefetch buffer to improve performance above 40 MHz, a 32 KBsingle-cycle SRAM, and internal ROM loaded with StellarisWare® software,a 2 KB EEPROM, one or more PWM modules, one or more QEI analogs, and/orone or more 12-bit ADCs with 12 analog input channels, details of whichare available for the product datasheet.

In one aspect, the microcontroller 461 may comprise a safety controllercomprising two controller-based families such as TMS570 and RM4x, knownunder the trade name Hercules ARM Cortex R4, also by Texas Instruments.The safety controller may be configured specifically for IEC 61508 andISO 26262 safety critical applications, among others, to provideadvanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The microcontroller 461 may be programmed to perform various functionssuch as precise control over the speed and position of the knife andarticulation systems. In one aspect, the microcontroller 461 may includea processor 462 and a memory 468. The electric motor 482 may be abrushed direct current (DC) motor with a gearbox and mechanical links toan articulation or knife system. In one aspect, a motor driver 492 maybe an A3941 available from Allegro Microsystems, Inc. Other motordrivers may be readily substituted for use in the tracking system 480comprising an absolute positioning system. A detailed description of anabsolute positioning system is described in U.S. Patent ApplicationPublication No. 2017/0296213, titled SYSTEMS AND METHODS FOR CONTROLLINGA SURGICAL STAPLING AND CUTTING INSTRUMENT, which published on Oct. 19,2017, which is herein incorporated by reference in its entirety.

The microcontroller 461 may be programmed to provide precise controlover the speed and position of displacement members and articulationsystems. The microcontroller 461 may be configured to compute a responsein the software of the microcontroller 461. The computed response may becompared to a measured response of the actual system to obtain an“observed” response, which is used for actual feedback decisions. Theobserved response may be a favorable, tuned value that balances thesmooth, continuous nature of the simulated response with the measuredresponse, which can detect outside influences on the system.

In some examples, the motor 482 may be controlled by the motor driver492 and can be employed by the firing system of the surgical instrumentor tool. In various forms, the motor 482 may be a brushed DC drivingmotor having a maximum rotational speed of approximately 25,000 RPM. Insome examples, the motor 482 may include a brushless motor, a cordlessmotor, a synchronous motor, a stepper motor, or any other suitableelectric motor. The motor driver 492 may comprise an H-bridge drivercomprising field-effect transistors (FETs), for example. The motor 482can be powered by a power assembly releasably mounted to the handleassembly or tool housing for supplying control power to the surgicalinstrument or tool. The power assembly may comprise a battery which mayinclude a number of battery cells connected in series that can be usedas the power source to power the surgical instrument or tool. In certaincircumstances, the battery cells of the power assembly may bereplaceable and/or rechargeable. In at least one example, the batterycells can be lithium-ion batteries which can be couplable to andseparable from the power assembly.

The motor driver 492 may be an A3941 available from AllegroMicrosystems, Inc. The A3941 492 may be a full-bridge controller for usewith external N-channel power metal-oxide semiconductor field-effecttransistors (MOSFETs) specifically designed for inductive loads, such asbrush DC motors. The driver 492 may comprise a unique charge pumpregulator that can provide full (>10 V) gate drive for battery voltagesdown to 7 V and can allow the A3941 to operate with a reduced gatedrive, down to 5.5 V. A bootstrap capacitor may be employed to providethe above battery supply voltage required for N-channel MOSFETs. Aninternal charge pump for the high-side drive may allow DC (100% dutycycle) operation. The full bridge can be driven in fast or slow decaymodes using diode or synchronous rectification. In the slow decay mode,current recirculation can be through the high-side or the lowside FETs.The power FETs may be protected from shoot-through byresistor-adjustable dead time. Integrated diagnostics provideindications of undervoltage, overtemperature, and power bridge faultsand can be configured to protect the power MOSFETs under most shortcircuit conditions. Other motor drivers may be readily substituted foruse in the tracking system 480 comprising an absolute positioningsystem.

The tracking system 480 may comprise a controlled motor drive circuitarrangement comprising a position sensor 472 according to one aspect ofthis disclosure. The position sensor 472 for an absolute positioningsystem may provide a unique position signal corresponding to thelocation of a displacement member. In some examples, the displacementmember may represent a longitudinally movable drive member comprising arack of drive teeth for meshing engagement with a corresponding drivegear of a gear reducer assembly. In some examples, the displacementmember may represent the firing member, which could be adapted andconfigured to include a rack of drive teeth. In some examples, thedisplacement member may represent a firing bar or the I-beam, each ofwhich can be adapted and configured to include a rack of drive teeth.Accordingly, as used herein, the term displacement member can be usedgenerically to refer to any movable member of the surgical instrument ortool such as the drive member, the firing member, the firing bar, theI-beam, or any element that can be displaced. In one aspect, thelongitudinally movable drive member can be coupled to the firing member,the firing bar, and the I-beam. Accordingly, the absolute positioningsystem can, in effect, track the linear displacement of the I-beam bytracking the linear displacement of the longitudinally movable drivemember. In various aspects, the displacement member may be coupled toany position sensor 472 suitable for measuring linear displacement.Thus, the longitudinally movable drive member, the firing member, thefiring bar, or the I-beam, or combinations thereof, may be coupled toany suitable linear displacement sensor. Linear displacement sensors mayinclude contact or non-contact displacement sensors. Linear displacementsensors may comprise linear variable differential transformers (LVDT),differential variable reluctance transducers (DVRT), a slidepotentiometer, a magnetic sensing system comprising a movable magnet anda series of linearly arranged Hall effect sensors, a magnetic sensingsystem comprising a fixed magnet and a series of movable, linearlyarranged Hall effect sensors, an optical sensing system comprising amovable light source and a series of linearly arranged photo diodes orphoto detectors, an optical sensing system comprising a fixed lightsource and a series of movable linearly, arranged photo diodes or photodetectors, or any combination thereof.

The electric motor 482 can include a rotatable shaft that operablyinterfaces with a gear assembly that is mounted in meshing engagementwith a set, or rack, of drive teeth on the displacement member. A sensorelement may be operably coupled to a gear assembly such that a singlerevolution of the position sensor 472 element corresponds to some linearlongitudinal translation of the displacement member. An arrangement ofgearing and sensors can be connected to the linear actuator, via a rackand pinion arrangement, or a rotary actuator, via a spur gear or otherconnection. A power source may supplie power to the absolute positioningsystem and an output indicator may display the output of the absolutepositioning system. The displacement member may represent thelongitudinally movable drive member comprising a rack of drive teethformed thereon for meshing engagement with a corresponding drive gear ofthe gear reducer assembly. The displacement member may represent thelongitudinally movable firing member, firing bar, I-beam, orcombinations thereof.

A single revolution of the sensor element associated with the positionsensor 472 may be equivalent to a longitudinal linear displacement d1 ofthe of the displacement member, where d1 is the longitudinal lineardistance that the displacement member moves from point “a” to point “b”after a single revolution of the sensor element coupled to thedisplacement member. The sensor arrangement may be connected via a gearreduction that results in the position sensor 472 completing one or morerevolutions for the full stroke of the displacement member. The positionsensor 472 may complete multiple revolutions for the full stroke of thedisplacement member.

A series of switches, where n is an integer greater than one, may beemployed alone or in combination with a gear reduction to provide aunique position signal for more than one revolution of the positionsensor 472. The state of the switches may be fed back to themicrocontroller 461 that applies logic to determine a unique positionsignal corresponding to the longitudinal linear displacement d1+d2+ . .. dn of the displacement member. The output of the position sensor 472is provided to the microcontroller 461. The position sensor 472 of thesensor arrangement may comprise a magnetic sensor, an analog rotarysensor like a potentiometer, or an array of analog Hall-effect elements,which output a unique combination of position signals or values.

The position sensor 472 may comprise any number of magnetic sensingelements, such as, for example, magnetic sensors classified according towhether they measure the total magnetic field or the vector componentsof the magnetic field. The techniques used to produce both types ofmagnetic sensors may encompass many aspects of physics and electronics.The technologies used for magnetic field sensing may include searchcoil, fluxgate, optically pumped, nuclear precession, SQUID,Hall-effect, anisotropic magnetoresistance, giant magnetoresistance,magnetic tunnel junctions, giant magnetoimpedance,magnetostrictive/piezoelectric composites, magnetodiode,magnetotransistor, fiber-optic, magneto-optic, andmicroelectromechanical systems-based magnetic sensors, among others.

In one aspect, the position sensor 472 for the tracking system 480comprising an absolute positioning system may comprise a magnetic rotaryabsolute positioning system. The position sensor 472 may be implementedas an AS5055EQFT single-chip magnetic rotary position sensor availablefrom Austria Microsystems, AG. The position sensor 472 is interfacedwith the microcontroller 461 to provide an absolute positioning system.The position sensor 472 may be a low-voltage and low-power component andincludes four Hall-effect elements in an area of the position sensor 472that may be located above a magnet. A high-resolution ADC and a smartpower management controller may also be provided on the chip. Acoordinate rotation digital computer (CORDIC) processor, also known asthe digit-by-digit method and Volder's algorithm, may be provided toimplement a simple and efficient algorithm to calculate hyperbolic andtrigonometric functions that require only addition, subtraction,bitshift, and table lookup operations. The angle position, alarm bits,and magnetic field information may be transmitted over a standard serialcommunication interface, such as a serial peripheral interface (SPI)interface, to the microcontroller 461. The position sensor 472 mayprovide 12 or 14 bits of resolution. The position sensor 472 may be anAS5055 chip provided in a small QFN 16-pin 4×4×0.85 mm package.

The tracking system 480 comprising an absolute positioning system maycomprise and/or be programmed to implement a feedback controller, suchas a PID, state feedback, and adaptive controller. A power sourceconverts the signal from the feedback controller into a physical inputto the system: in this case the voltage. Other examples include a PWM ofthe voltage, current, and force. Other sensor(s) may be provided tomeasure physical parameters of the physical system in addition to theposition measured by the position sensor 472. In some aspects, the othersensor(s) can include sensor arrangements such as those described inU.S. Pat. No. 9,345,481, titled STAPLE CARTRIDGE TISSUE THICKNESS SENSORSYSTEM, which issued on May 24, 2016, which is herein incorporated byreference in its entirety; U.S. Patent Application Publication No.2014/0263552, titled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM,which published on Sep. 18, 2014, which is herein incorporated byreference in its entirety; and U.S. patent application Ser. No.15/628,175, titled TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OFA SURGICAL STAPLING AND CUTTING INSTRUMENT, filed Jun. 20, 2017, whichis herein incorporated by reference in its entirety. In a digital signalprocessing system, an absolute positioning system is coupled to adigital data acquisition system where the output of the absolutepositioning system will have a finite resolution and sampling frequency.The absolute positioning system may comprise a compare-and-combinecircuit to combine a computed response with a measured response usingalgorithms, such as a weighted average and a theoretical control loop,that drive the computed response towards the measured response. Thecomputed response of the physical system may take into accountproperties like mass, inertial, viscous friction, inductance resistance,etc., to predict what the states and outputs of the physical system willbe by knowing the input.

The absolute positioning system may provide an absolute position of thedisplacement member upon power-up of the instrument, without retractingor advancing the displacement member to a reset (zero or home) positionas may be required with conventional rotary encoders that merely countthe number of steps forwards or backwards that the motor 482 has takento infer the position of a device actuator, drive bar, knife, or thelike.

A sensor 474, such as, for example, a strain gauge or a micro-straingauge, may be configured to measure one or more parameters of the endeffector, such as, for example, the amplitude of the strain exerted onthe anvil during a clamping operation, which can be indicative of theclosure forces applied to the anvil. The measured strain may beconverted to a digital signal and provided to the processor 462.Alternatively, or in addition to the sensor 474, a sensor 476, such as,for example, a load sensor, can measure the closure force applied by theclosure drive system to the anvil. The sensor 476, such as, for example,a load sensor, can measure the firing force applied to an I-beam in afiring stroke of the surgical instrument or tool. The I-beam isconfigured to engage a wedge sled, which is configured to upwardly camstaple drivers to force out staples into deforming contact with ananvil. The I-beam also may include a sharpened cutting edge that can beused to sever tissue as the I-beam is advanced distally by the firingbar. Alternatively, a current sensor 478 can be employed to measure thecurrent drawn by the motor 482. The force required to advance the firingmember can correspond to the current drawn by the motor 482, forexample. The measured force may be converted to a digital signal andprovided to the processor 462.

In one form, the strain gauge sensor 474 can be used to measure theforce applied to the tissue by the end effector. A strain gauge can becoupled to the end effector to measure the force on the tissue beingtreated by the end effector. A system for measuring forces applied tothe tissue grasped by the end effector may comprise a strain gaugesensor 474, such as, for example, a micro-strain gauge, that can beconfigured to measure one or more parameters of the end effector, forexample. In one aspect, the strain gauge sensor 474 can measure theamplitude or magnitude of the strain exerted on a jaw member of an endeffector during a clamping operation, which can be indicative of thetissue compression. The measured strain can be converted to a digitalsignal and provided to a processor 462 of the microcontroller 461. Aload sensor 476 can measure the force used to operate the knife element,for example, to cut the tissue captured between the anvil and the staplecartridge. A magnetic field sensor can be employed to measure thethickness of the captured tissue. The measurement of the magnetic fieldsensor also may be converted to a digital signal and provided to theprocessor 462.

The measurements of the tissue compression, the tissue thickness, and/orthe force required to close the end effector on the tissue, asrespectively measured by the sensors 474, 476, can be used by themicrocontroller 461 to characterize the selected position of the firingmember and/or the corresponding value of the speed of the firing member.In one instance, a memory 468 may store a technique, an equation, and/ora lookup table which can be employed by the microcontroller 461 in theassessment.

The control system 470 of the surgical instrument or tool also maycomprise wired or wireless communication circuits to communicate withthe modular communication hub 203 as shown in FIGS. 5 and 6.

FIG. 8 illustrates a surgical instrument or tool comprising a pluralityof motors which can be activated to perform various functions. Incertain instances, a first motor can be activated to perform a firstfunction, a second motor can be activated to perform a second function,a third motor can be activated to perform a third function, a fourthmotor can be activated to perform a fourth function, and so on Incertain instances, the plurality of motors of robotic surgicalinstrument 600 can be individually activated to cause firing, closure,and/or articulation motions in the end effector. The firing, closure,and/or articulation motions can be transmitted to the end effectorthrough a shaft assembly, for example.

In certain instances, the surgical instrument system or tool may includea firing motor 602. The firing motor 602 may be operably coupled to afiring motor drive assembly 604 which can be configured to transmitfiring motions, generated by the motor 602 to the end effector, inparticular to displace the I-beam element. In certain instances, thefiring motions generated by the motor 602 may cause the staples to bedeployed from the staple cartridge into tissue captured by the endeffector and/or the cutting edge of the I-beam element to be advanced tocut the captured tissue, for example. The I-beam element may beretracted by reversing the direction of the motor 602.

In certain instances, the surgical instrument or tool may include aclosure motor 603. The closure motor 603 may be operably coupled to aclosure motor drive assembly 605 which can be configured to transmitclosure motions, generated by the motor 603 to the end effector, inparticular to displace a closure tube to close the anvil and compresstissue between the anvil and the staple cartridge. The closure motionsmay cause the end effector to transition from an open configuration toan approximated configuration to capture tissue, for example. The endeffector may be transitioned to an open position by reversing thedirection of the motor 603.

In certain instances, the surgical instrument or tool may include one ormore articulation motors 606 a, 606 b, for example. The motors 606 a,606 b may be operably coupled to respective articulation motor driveassemblies 608 a, 608 b, which can be configured to transmitarticulation motions generated by the motors 606 a, 606 b to the endeffector. In certain instances, the articulation motions may cause theend effector to articulate relative to the shaft, for example.

As described herein, the surgical instrument or tool may include aplurality of motors which may be configured to perform variousindependent functions. In certain instances, the plurality of motors ofthe surgical instrument or tool can be individually or separatelyactivated to perform one or more functions while the other motors remaininactive. For example, the articulation motors 606 a, 606 b can beactivated to cause the end effector to be articulated while the firingmotor 602 remains inactive. Alternatively, the firing motor 602 can beactivated to fire the plurality of staples, and/or to advance thecutting edge, while the articulation motor 606 remains inactive.Furthermore, the closure motor 603 may be activated simultaneously withthe firing motor 602 to cause the closure tube and the I-beam element toadvance distally as described in more detail hereinbelow.

In certain instances, the surgical instrument or tool may include acommon control module 610 which can be employed with a plurality ofmotors of the surgical instrument or tool. In certain instances, thecommon control module 610 may accommodate one of the plurality of motorsat a time. For example, the common control module 610 can be couplableto and separable from the plurality of motors of the robotic surgicalinstrument individually. In certain instances, a plurality of the motorsof the surgical instrument or tool may share one or more common controlmodules such as the common control module 610. In certain instances, aplurality of motors of the surgical instrument or tool can beindividually and selectively engaged with the common control module 610.In certain instances, the common control module 610 can be selectivelyswitched from interfacing with one of a plurality of motors of thesurgical instrument or tool to interfacing with another one of theplurality of motors of the surgical instrument or tool.

In at least one example, the common control module 610 can beselectively switched between operable engagement with the articulationmotors 606 a, 606 b and operable engagement with either the firing motor602 or the closure motor 603. In at least one example, as illustrated inFIG. 8, a switch 614 can be moved or transitioned between a plurality ofpositions and/or states. In a first position 616, the switch 614 mayelectrically couple the common control module 610 to the firing motor602; in a second position 617, the switch 614 may electrically couplethe common control module 610 to the closure motor 603; in a thirdposition 618 a, the switch 614 may electrically couple the commoncontrol module 610 to the first articulation motor 606 a; and in afourth position 618 b, the switch 614 may electrically couple the commoncontrol module 610 to the second articulation motor 606 b, for example.In certain instances, separate common control modules 610 can beelectrically coupled to the firing motor 602, the closure motor 603, andthe articulations motor 606 a, 606 b at the same time. In certaininstances, the switch 614 may be a mechanical switch, anelectromechanical switch, a solid-state switch, or any suitableswitching mechanism.

Each of the motors 602, 603, 606 a, 606 b may comprise a torque sensorto measure the output torque on the shaft of the motor. The force on anend effector may be sensed in any conventional manner, such as by forcesensors on the outer sides of the jaws or by a torque sensor for themotor actuating the jaws.

In various instances, as illustrated in FIG. 8, the common controlmodule 610 may comprise a motor driver 626 which may comprise one ormore H-Bridge FETs. The motor driver 626 may modulate the powertransmitted from a power source 628 to a motor coupled to the commoncontrol module 610 based on input from a microcontroller 620 (the“controller”), for example. In certain instances, the microcontroller620 can be employed to determine the current drawn by the motor, forexample, while the motor is coupled to the common control module 610, asdescribed herein.

In certain instances, the microcontroller 620 may include amicroprocessor 622 (the “processor”) and one or more non-transitorycomputer-readable mediums or memory units 624 (the “memory”). In certaininstances, the memory 624 may store various program instructions, whichwhen executed may cause the processor 622 to perform a plurality offunctions and/or calculations described herein. In certain instances,one or more of the memory units 624 may be coupled to the processor 622,for example.

In certain instances, the power source 628 can be employed to supplypower to the microcontroller 620, for example. In certain instances, thepower source 628 may comprise a battery (or “battery pack” or “powerpack”), such as a lithium-ion battery, for example. In certaininstances, the battery pack may be configured to be releasably mountedto a handle for supplying power to the surgical instrument 600. A numberof battery cells connected in series may be used as the power source628. In certain instances, the power source 628 may be replaceableand/or rechargeable, for example.

In various instances, the processor 622 may control the motor driver 626to control the position, direction of rotation, and/or velocity of amotor that is coupled to the common control module 610. In certaininstances, the processor 622 can signal the motor driver 626 to stopand/or disable a motor that is coupled to the common control module 610.It should be understood that the term “processor” as used hereinincludes any suitable microprocessor, microcontroller, or other basiccomputing device that incorporates the functions of a computer's centralprocessing unit (CPU) on an integrated circuit or, at most, a fewintegrated circuits. The processor can be a multipurpose, programmabledevice that accepts digital data as input, processes it according toinstructions stored in its memory, and provides results as output. Itcan be an example of sequential digital logic, as it may have internalmemory. Processors may operate on numbers and symbols represented in thebinary numeral system.

The processor 622 may be any single-core or multicore processor such asthose known under the trade name ARM Cortex by Texas Instruments. Incertain instances, the microcontroller 620 may be an LM 4F230H5QR,available from Texas Instruments, for example. In at least one example,the Texas Instruments LM4F230H5QR is an ARM Cortex-M4F Processor Corecomprising an on-chip memory of 256 KB single-cycle flash memory, orother non-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle SRAM, an internal ROMloaded with StellarisWare® software, a 2 KB EEPROM, one or more PWMmodules, one or more QEI analogs, one or more 12-bit ADCs with 12 analoginput channels, among other features that are readily available for theproduct datasheet. Other microcontrollers may be readily substituted foruse with the module 4410. Accordingly, the present disclosure should notbe limited in this context.

The memory 624 may include program instructions for controlling each ofthe motors of the surgical instrument 600 that are couplable to thecommon control module 610. For example, the memory 624 may includeprogram instructions for controlling the firing motor 602, the closuremotor 603, and the articulation motors 606 a, 606 b. Such programinstructions may cause the processor 622 to control the firing, closure,and articulation functions in accordance with inputs from algorithms orcontrol programs of the surgical instrument or tool.

One or more mechanisms and/or sensors such as, for example, sensors 630can be employed to alert the processor 622 to the program instructionsthat should be used in a particular setting. For example, the sensors630 may alert the processor 622 to use the program instructionsassociated with firing, closing, and articulating the end effector. Incertain instances, the sensors 630 may comprise position sensors whichcan be employed to sense the position of the switch 614, for example.Accordingly, the processor 622 may use the program instructionsassociated with firing the I-beam of the end effector upon detecting,through the sensors 630 for example, that the switch 614 is in the firstposition 616; the processor 622 may use the program instructionsassociated with closing the anvil upon detecting, through the sensors630 for example, that the switch 614 is in the second position 617; andthe processor 622 may use the program instructions associated witharticulating the end effector upon detecting, through the sensors 630for example, that the switch 614 is in the third or fourth position 618a, 618 b.

FIG. 9 illustrates a diagram of a situationally aware surgical system5100, in accordance with at least one aspect of the present disclosure.In some exemplifications, the data sources 5126 may include, forexample, the modular devices 5102 (which can include sensors configuredto detect parameters associated with the patient and/or the modulardevice itself), databases 5122 (e.g., an EMR database containing patientrecords), and patient monitoring devices 5124 (e.g., a blood pressure(BP) monitor and an electrocardiography (EKG) monitor). The surgical hub5104 can be configured to derive the contextual information pertainingto the surgical procedure from the data based upon, for example, theparticular combination(s) of received data or the particular order inwhich the data is received from the data sources 5126. The contextualinformation inferred from the received data can include, for example,the type of surgical procedure being performed, the particular step ofthe surgical procedure that the surgeon is performing, the type oftissue being operated on, or the body cavity that is the subject of theprocedure. This ability by some aspects of the surgical hub 5104 toderive or infer information related to the surgical procedure fromreceived data can be referred to as “situational awareness.” In anexemplification, the surgical hub 5104 can incorporate a situationalawareness system, which is the hardware and/or programming associatedwith the surgical hub 5104 that derives contextual informationpertaining to the surgical procedure from the received data.

The situational awareness system of the surgical hub 5104 can beconfigured to derive the contextual information from the data receivedfrom the data sources 5126 in a variety of different ways. In anexemplification, the situational awareness system can include a patternrecognition system, or machine learning system (e.g., an artificialneural network), that has been trained on training data to correlatevarious inputs (e.g., data from databases 5122, patient monitoringdevices 5124, and/or modular devices 5102) to corresponding contextualinformation regarding a surgical procedure. In other words, a machinelearning system can be trained to accurately derive contextualinformation regarding a surgical procedure from the provided inputs. Inexamples, the situational awareness system can include a lookup tablestoring pre-characterized contextual information regarding a surgicalprocedure in association with one or more inputs (or ranges of inputs)corresponding to the contextual information. In response to a query withone or more inputs, the look-up table can return the correspondingcontextual information for the situational awareness system forcontrolling the modular devices 5102. In examples, the contextualinformation received by the situational awareness system of the surgicalhub 5104 can be associated with a particular control adjustment or setof control adjustments for one or more modular devices 5102. Inexamples, the situational awareness system can include a further machinelearning system, lookup table, or other such system, which generates orretrieves one or more control adjustments for one or more modulardevices 5102 when provided the contextual information as input.

A surgical hub 5104 incorporating a situational awareness system canprovide a number of benefits for the surgical system 5100. One benefitmay include improving the interpretation of sensed and collected data,which would in turn improve the processing accuracy and/or the usage ofthe data during the course of a surgical procedure. To return to aprevious example, a situationally aware surgical hub 5104 coulddetermine what type of tissue was being operated on; therefore, when anunexpectedly high force to close the surgical instrument's end effectoris detected, the situationally aware surgical hub 5104 could correctlyramp up or ramp down the motor of the surgical instrument for the typeof tissue.

The type of tissue being operated can affect the adjustments that aremade to the compression rate and load thresholds of a surgical staplingand cutting instrument for a particular tissue gap measurement. Asituationally aware surgical hub 5104 could infer whether a surgicalprocedure being performed is a thoracic or an abdominal procedure,allowing the surgical hub 5104 to determine whether the tissue clampedby an end effector of the surgical stapling and cutting instrument islung (for a thoracic procedure) or stomach (for an abdominal procedure)tissue. The surgical hub 5104 could then adjust the compression rate andload thresholds of the surgical stapling and cutting instrumentappropriately for the type of tissue.

The type of body cavity being operated in during an insufflationprocedure can affect the function of a smoke evacuator. A situationallyaware surgical hub 5104 could determine whether the surgical site isunder pressure (by determining that the surgical procedure is utilizinginsufflation) and determine the procedure type. As a procedure type canbe generally performed in a specific body cavity, the surgical hub 5104could then control the motor rate of the smoke evacuator appropriatelyfor the body cavity being operated in. Thus, a situationally awaresurgical hub 5104 could provide a consistent amount of smoke evacuationfor both thoracic and abdominal procedures.

The type of procedure being performed can affect the optimal energylevel for an ultrasonic surgical instrument or radio frequency (RF)electrosurgical instrument to operate at. Arthroscopic procedures, forexample, may require higher energy levels because the end effector ofthe ultrasonic surgical instrument or RF electrosurgical instrument isimmersed in fluid. A situationally aware surgical hub 5104 coulddetermine whether the surgical procedure is an arthroscopic procedure.The surgical hub 5104 could then adjust the RF power level or theultrasonic amplitude of the generator (i.e., “energy level”) tocompensate for the fluid filled environment. Relatedly, the type oftissue being operated on can affect the optimal energy level for anultrasonic surgical instrument or RF electrosurgical instrument tooperate at. A situationally aware surgical hub 5104 could determine whattype of surgical procedure is being performed and then customize theenergy level for the ultrasonic surgical instrument or RFelectrosurgical instrument, respectively, according to the expectedtissue profile for the surgical procedure. Furthermore, a situationallyaware surgical hub 5104 can be configured to adjust the energy level forthe ultrasonic surgical instrument or RF electrosurgical instrumentthroughout the course of a surgical procedure, rather than just on aprocedure-by-procedure basis. A situationally aware surgical hub 5104could determine what step of the surgical procedure is being performedor will subsequently be performed and then update the control algorithmsfor the generator and/or ultrasonic surgical instrument or RFelectrosurgical instrument to set the energy level at a valueappropriate for the expected tissue type according to the surgicalprocedure step.

In examples, data can be drawn from additional data sources 5126 toimprove the conclusions that the surgical hub 5104 draws from one datasource 5126. A situationally aware surgical hub 5104 could augment datathat it receives from the modular devices 5102 with contextualinformation that it has built up regarding the surgical procedure fromother data sources 5126. For example, a situationally aware surgical hub5104 can be configured to determine whether hemostasis has occurred(i.e., whether bleeding at a surgical site has stopped) according tovideo or image data received from a medical imaging device. However, insome cases the video or image data can be inconclusive. Therefore, in anexemplification, the surgical hub 5104 can be further configured tocompare a physiologic measurement (e.g., blood pressure sensed by a BPmonitor communicably connected to the surgical hub 5104) with the visualor image data of hemostasis (e.g., from a medical imaging device 124(FIG. 2) communicably coupled to the surgical hub 5104) to make adetermination on the integrity of the staple line or tissue weld. Inother words, the situational awareness system of the surgical hub 5104can consider the physiological measurement data to provide additionalcontext in analyzing the visualization data. The additional context canbe useful when the visualization data may be inconclusive or incompleteon its own.

For example, a situationally aware surgical hub 5104 could proactivelyactivate the generator to which an RF electrosurgical instrument isconnected if it determines that a subsequent step of the procedurerequires the use of the instrument. Proactively activating the energysource can allow the instrument to be ready for use a soon as thepreceding step of the procedure is completed.

The situationally aware surgical hub 5104 could determine whether thecurrent or subsequent step of the surgical procedure requires adifferent view or degree of magnification on the display according tothe feature(s) at the surgical site that the surgeon is expected to needto view. The surgical hub 5104 could then proactively change thedisplayed view (supplied by, e.g., a medical imaging device for thevisualization system 108) accordingly so that the display automaticallyadjusts throughout the surgical procedure.

The situationally aware surgical hub 5104 could determine which step ofthe surgical procedure is being performed or will subsequently beperformed and whether particular data or comparisons between data willbe required for that step of the surgical procedure. The surgical hub5104 can be configured to automatically call up data screens based uponthe step of the surgical procedure being performed, without waiting forthe surgeon to ask for the particular information.

Errors may be checked during the setup of the surgical procedure orduring the course of the surgical procedure. For example, thesituationally aware surgical hub 5104 could determine whether theoperating theater is setup properly or optimally for the surgicalprocedure to be performed. The surgical hub 5104 can be configured todetermine the type of surgical procedure being performed, retrieve thecorresponding checklists, product location, or setup needs (e.g., from amemory), and then compare the current operating theater layout to thestandard layout for the type of surgical procedure that the surgical hub5104 determines is being performed. In some exemplifications, thesurgical hub 5104 can be configured to compare the list of items for theprocedure and/or a list of devices paired with the surgical hub 5104 toa recommended or anticipated manifest of items and/or devices for thegiven surgical procedure. If there are any discontinuities between thelists, the surgical hub 5104 can be configured to provide an alertindicating that a particular modular device 5102, patient monitoringdevice 5124, and/or other surgical item is missing. In someexemplifications, the surgical hub 5104 can be configured to determinethe relative distance or position of the modular devices 5102 andpatient monitoring devices 5124 via proximity sensors, for example. Thesurgical hub 5104 can compare the relative positions of the devices to arecommended or anticipated layout for the particular surgical procedure.If there are any discontinuities between the layouts, the surgical hub5104 can be configured to provide an alert indicating that the currentlayout for the surgical procedure deviates from the recommended layout.

The situationally aware surgical hub 5104 could determine whether thesurgeon (or other medical personnel) was making an error or otherwisedeviating from the expected course of action during the course of asurgical procedure. For example, the surgical hub 5104 can be configuredto determine the type of surgical procedure being performed, retrievethe corresponding list of steps or order of equipment usage (e.g., froma memory), and then compare the steps being performed or the equipmentbeing used during the course of the surgical procedure to the expectedsteps or equipment for the type of surgical procedure that the surgicalhub 5104 determined is being performed. In some exemplifications, thesurgical hub 5104 can be configured to provide an alert indicating thatan unexpected action is being performed or an unexpected device is beingutilized at the particular step in the surgical procedure.

The surgical instruments (and other modular devices 5102) may beadjusted for the particular context of each surgical procedure (such asadjusting to different tissue types) and validating actions during asurgical procedure. Next steps, data, and display adjustments may beprovided to surgical instruments (and other modular devices 5102) in thesurgical theater according to the specific context of the procedure.

FIG. 10 illustrates a timeline 5200 of an illustrative surgicalprocedure and the contextual information that a surgical hub 5104 canderive from the data received from the data sources 5126 at each step inthe surgical procedure. In the following description of the timeline5200 illustrated in FIG. 9, reference should also be made to FIG. 9. Thetimeline 5200 may depict the typical steps that would be taken by thenurses, surgeons, and other medical personnel during the course of alung segmentectomy procedure, beginning with setting up the operatingtheater and ending with transferring the patient to a post-operativerecovery room. The situationally aware surgical hub 5104 may receivedata from the data sources 5126 throughout the course of the surgicalprocedure, including data generated each time medical personnel utilizea modular device 5102 that is paired with the surgical hub 5104. Thesurgical hub 5104 can receive this data from the paired modular devices5102 and other data sources 5126 and continually derive inferences(i.e., contextual information) about the ongoing procedure as new datais received, such as which step of the procedure is being performed atany given time. The situational awareness system of the surgical hub5104 can be able to, for example, record data pertaining to theprocedure for generating reports, verify the steps being taken by themedical personnel, provide data or prompts (e.g., via a display screen)that may be pertinent for the particular procedural step, adjust modulardevices 5102 based on the context (e.g., activate monitors, adjust theFOV of the medical imaging device, or change the energy level of anultrasonic surgical instrument or RF electrosurgical instrument), andtake any other such action described herein.

As the first step 5202 in this illustrative procedure, the hospitalstaff members may retrieve the patient's EMR from the hospital's EMRdatabase. Based on select patient data in the EMR, the surgical hub 5104determines that the procedure to be performed is a thoracic procedure.Second 5204, the staff members may scan the incoming medical suppliesfor the procedure. The surgical hub 5104 cross-references the scannedsupplies with a list of supplies that can be utilized in various typesof procedures and confirms that the mix of supplies corresponds to athoracic procedure. Further, the surgical hub 5104 may also be able todetermine that the procedure is not a wedge procedure (because theincoming supplies either lack certain supplies that are necessary for athoracic wedge procedure or do not otherwise correspond to a thoracicwedge procedure). Third 5206, the medical personnel may scan the patientband via a scanner 5128 that is communicably connected to the surgicalhub 5104. The surgical hub 5104 can then confirm the patient's identitybased on the scanned data. Fourth 5208, the medical staff turns on theauxiliary equipment. The auxiliary equipment being utilized can varyaccording to the type of surgical procedure and the techniques to beused by the surgeon, but in this illustrative case they include a smokeevacuator, insufflator, and medical imaging device. When activated, theauxiliary equipment that are modular devices 5102 can automatically pairwith the surgical hub 5104 that may be located within a particularvicinity of the modular devices 5102 as part of their initializationprocess. The surgical hub 5104 can then derive contextual informationabout the surgical procedure by detecting the types of modular devices5102 that pair with it during this pre-operative or initializationphase. In this particular example, the surgical hub 5104 may determinethat the surgical procedure is a VATS procedure based on this particularcombination of paired modular devices 5102. Based on the combination ofthe data from the patient's EMR, the list of medical supplies to be usedin the procedure, and the type of modular devices 5102 that connect tothe hub, the surgical hub 5104 can generally infer the specificprocedure that the surgical team will be performing. Once the surgicalhub 5104 knows what specific procedure is being performed, the surgicalhub 5104 can then retrieve the steps of that procedure from a memory orfrom the cloud and then cross-reference the data it subsequentlyreceives from the connected data sources 5126 (e.g., modular devices5102 and patient monitoring devices 5124) to infer what step of thesurgical procedure the surgical team is performing. Fifth 5210, thestaff members attach the EKG electrodes and other patient monitoringdevices 5124 to the patient. The EKG electrodes and other patientmonitoring devices 5124 may pair with the surgical hub 5104. As thesurgical hub 5104 begins receiving data from the patient monitoringdevices 5124, the surgical hub 5104 may confirm that the patient is inthe operating theater, as described in the process 5207, for example.Sixth 5212, the medical personnel may induce anesthesia in the patient.The surgical hub 5104 can infer that the patient is under anesthesiabased on data from the modular devices 5102 and/or patient monitoringdevices 5124, including EKG data, blood pressure data, ventilator data,or combinations thereof, for example. Upon completion of the sixth step5212, the pre-operative portion of the lung segmentectomy procedure iscompleted and the operative portion begins.

Seventh 5214, the patient's lung that is being operated on may becollapsed (while ventilation is switched to the contralateral lung). Thesurgical hub 5104 can infer from the ventilator data that the patient'slung has been collapsed, for example. The surgical hub 5104 can inferthat the operative portion of the procedure has commenced as it cancompare the detection of the patient's lung collapsing to the expectedsteps of the procedure (which can be accessed or retrieved previously)and thereby determine that collapsing the lung can be the firstoperative step in this particular procedure. Eighth 5216, the medicalimaging device 5108 (e.g., a scope) may be inserted and video from themedical imaging device may be initiated. The surgical hub 5104 mayreceive the medical imaging device data (i.e., video or image data)through its connection to the medical imaging device. Upon receipt ofthe medical imaging device data, the surgical hub 5104 can determinethat the laparoscopic portion of the surgical procedure has commenced.Further, the surgical hub 5104 can determine that the particularprocedure being performed is a segmentectomy, as opposed to a lobectomy(note that a wedge procedure has already been discounted by the surgicalhub 5104 based on data received at the second step 5204 of theprocedure). The data from the medical imaging device 124 (FIG. 2) can beutilized to determine contextual information regarding the type ofprocedure being performed in a number of different ways, including bydetermining the angle at which the medical imaging device is orientedwith respect to the visualization of the patient's anatomy, monitoringthe number or medical imaging devices being utilized (i.e., that areactivated and paired with the surgical hub 5104), and monitoring thetypes of visualization devices utilized. For example, one technique forperforming a VATS lobectomy may place the camera in the lower anteriorcorner of the patient's chest cavity above the diaphragm, whereas onetechnique for performing a VATS segmentectomy places the camera in ananterior intercostal position relative to the segmental fissure. Usingpattern recognition or machine learning techniques, for example, thesituational awareness system can be trained to recognize the positioningof the medical imaging device according to the visualization of thepatient's anatomy. An example technique for performing a VATS lobectomymay utilize a single medical imaging device. An example technique forperforming a VATS segmentectomy utilizes multiple cameras. An exampletechnique for performing a VATS segmentectomy utilizes an infrared lightsource (which can be communicably coupled to the surgical hub as part ofthe visualization system) to visualize the segmental fissure, which isnot utilized in a VATS lobectomy. By tracking any or all of this datafrom the medical imaging device 5108, the surgical hub 5104 can therebydetermine the specific type of surgical procedure being performed and/orthe technique being used for a particular type of surgical procedure.

Ninth 5218, the surgical team may begin the dissection step of theprocedure. The surgical hub 5104 can infer that the surgeon is in theprocess of dissecting to mobilize the patient's lung because it receivesdata from the RF or ultrasonic generator indicating that an energyinstrument is being fired. The surgical hub 5104 can cross-reference thereceived data with the retrieved steps of the surgical procedure todetermine that an energy instrument being fired at this point in theprocess (i.e., after the completion of the previously discussed steps ofthe procedure) corresponds to the dissection step. Tenth 5220, thesurgical team may proceed to the ligation step of the procedure. Thesurgical hub 5104 can infer that the surgeon is ligating arteries andveins because it may receive data from the surgical stapling and cuttinginstrument indicating that the instrument is being fired. Similar to theprior step, the surgical hub 5104 can derive this inference bycross-referencing the receipt of data from the surgical stapling andcutting instrument with the retrieved steps in the process. Eleventh5222, the segmentectomy portion of the procedure can be performed. Thesurgical hub 5104 can infer that the surgeon is transecting theparenchyma based on data from the surgical stapling and cuttinginstrument, including data from its cartridge. The cartridge data cancorrespond to the size or type of staple being fired by the instrument,for example. As different types of staples are utilized for differenttypes of tissues, the cartridge data can thus indicate the type oftissue being stapled and/or transected. In this case, the type of staplebeing fired is utilized for parenchyma (or other similar tissue types),which allows the surgical hub 5104 to infer that the segmentectomyportion of the procedure is being performed. Twelfth 5224, the nodedissection step is then performed. The surgical hub 5104 can infer thatthe surgical team is dissecting the node and performing a leak testbased on data received from the generator indicating that an RF orultrasonic instrument is being fired. For this particular procedure, anRF or ultrasonic instrument being utilized after parenchyma wastransected corresponds to the node dissection step, which allows thesurgical hub 5104 to make this inference. It should be noted thatsurgeons regularly switch back and forth between surgicalstapling/cutting instruments and surgical energy (e.g., RF orultrasonic) instruments depending upon the particular step in theprocedure because different instruments are better adapted forparticular tasks. Therefore, the particular sequence in which thestapling/cutting instruments and surgical energy instruments are usedcan indicate what step of the procedure the surgeon is performing. Uponcompletion of the twelfth step 5224, the incisions and closed up and thepost-operative portion of the procedure may begin.

Thirteenth 5226, the patient's anesthesia can be reversed. The surgicalhub 5104 can infer that the patient is emerging from the anesthesiabased on the ventilator data (i.e., the patient's breathing rate beginsincreasing), for example. Lastly, the fourteenth step 5228 may be thatthe medical personnel remove the various patient monitoring devices 5124from the patient. The surgical hub 5104 can thus infer that the patientis being transferred to a recovery room when the hub loses EKG, BP, andother data from the patient monitoring devices 5124. As can be seen fromthe description of this illustrative procedure, the surgical hub 5104can determine or infer when each step of a given surgical procedure istaking place according to data received from the various data sources5126 that are communicably coupled to the surgical hub 5104.

In addition to utilizing the patient data from EMR database(s) to inferthe type of surgical procedure that is to be performed, as illustratedin the first step 5202 of the timeline 5200 depicted in FIG. 10, thepatient data can also be utilized by a situationally aware surgical hub5104 to generate control adjustments for the paired modular devices5102.

FIG. 11 is a block diagram of the computer-implemented interactivesurgical system, in accordance with at least one aspect of the presentdisclosure. In one aspect, the computer-implemented interactive surgicalsystem may be configured to monitor and analyze data related to theoperation of various surgical systems that include surgical hubs,surgical instruments, robotic devices and operating theaters orhealthcare facilities. The computer-implemented interactive surgicalsystem may comprise a cloud-based analytics system. Although thecloud-based analytics system may be described as a surgical system, itmay not be necessarily limited as such and could be a cloud-basedmedical system generally. As illustrated in FIG. 11, the cloud-basedanalytics system may comprise a plurality of surgical instruments 7012(may be the same or similar to instruments 112), a plurality of surgicalhubs 7006 (may be the same or similar to hubs 106), and a surgical datanetwork 7001 (may be the same or similar to network 201) to couple thesurgical hubs 7006 to the cloud 7004 (may be the same or similar tocloud 204). Each of the plurality of surgical hubs 7006 may becommunicatively coupled to one or more surgical instruments 7012. Thehubs 7006 may also be communicatively coupled to the cloud 7004 of thecomputer-implemented interactive surgical system via the network 7001.The cloud 7004 may be a remote centralized source of hardware andsoftware for storing, manipulating, and communicating data generatedbased on the operation of various surgical systems. As shown in FIG. 11,access to the cloud 7004 may be achieved via the network 7001, which maybe the Internet or some other suitable computer network. Surgical hubs7006 that may be coupled to the cloud 7004 can be considered the clientside of the cloud computing system (i.e., cloud-based analytics system).Surgical instruments 7012 may be paired with the surgical hubs 7006 forcontrol and implementation of various surgical procedures or operationsas described herein.

In addition, surgical instruments 7012 may comprise transceivers fordata transmission to and from their corresponding surgical hubs 7006(which may also comprise transceivers). Combinations of surgicalinstruments 7012 and corresponding hubs 7006 may indicate particularlocations, such as operating theaters in healthcare facilities (e.g.,hospitals), for providing medical operations. For example, the memory ofa surgical hub 7006 may store location data. As shown in FIG. 11, thecloud 7004 comprises central servers 7013 (may be same or similar toremote server 7013), hub application servers 7002, data analyticsmodules 7034, and an input/output (“I/O”) interface 7006. The centralservers 7013 of the cloud 7004 collectively administer the cloudcomputing system, which includes monitoring requests by client surgicalhubs 7006 and managing the processing capacity of the cloud 7004 forexecuting the requests. Each of the central servers 7013 may compriseone or more processors 7008 coupled to suitable memory devices 7010which can include volatile memory such as random-access memory (RAM) andnon-volatile memory such as magnetic storage devices. The memory devices7010 may comprise machine executable instructions that when executedcause the processors 7008 to execute the data analytics modules 7034 forthe cloud-based data analysis, operations, recommendations and otheroperations described below. Moreover, the processors 7008 can executethe data analytics modules 7034 independently or in conjunction with hubapplications independently executed by the hubs 7006. The centralservers 7013 also may comprise aggregated medical data databases 2212,which can reside in the memory 2210.

Based on connections to various surgical hubs 7006 via the network 7001,the cloud 7004 can aggregate data from specific data generated byvarious surgical instruments 7012 and their corresponding hubs 7006.Such aggregated data may be stored within the aggregated medicaldatabases 7012 of the cloud 7004. In particular, the cloud 7004 mayadvantageously perform data analysis and operations on the aggregateddata to yield insights and/or perform functions that individual hubs7006 could not achieve on their own. To this end, as shown in FIG. 11,the cloud 7004 and the surgical hubs 7006 are communicatively coupled totransmit and receive information. The I/O interface 7006 is connected tothe plurality of surgical hubs 7006 via the network 7001. In this way,the I/O interface 7006 can be configured to transfer information betweenthe surgical hubs 7006 and the aggregated medical data databases 7011.Accordingly, the I/O interface 7006 may facilitate read/write operationsof the cloud-based analytics system. Such read/write operations may beexecuted in response to requests from hubs 7006. These requests could betransmitted to the hubs 7006 through the hub applications. The I/Ointerface 7006 may include one or more high speed data ports, which mayinclude universal serial bus (USB) ports, IEEE 1394 ports, as well asWi-Fi and Bluetooth I/O interfaces for connecting the cloud 7004 to hubs7006. The hub application servers 7002 of the cloud 7004 may beconfigured to host and supply shared capabilities to softwareapplications (e.g., hub applications) executed by surgical hubs 7006.For example, the hub application servers 7002 may manage requests madeby the hub applications through the hubs 7006, control access to theaggregated medical data databases 7011, and perform load balancing. Thedata analytics modules 7034 are described in further detail withreference to FIG. 12.

The particular cloud computing system configuration described in thepresent disclosure may be specifically designed to address variousissues arising in the context of medical operations and proceduresperformed using medical devices, such as the surgical instruments 7012,112. In particular, the surgical instruments 7012 may be digitalsurgical devices configured to interact with the cloud 7004 forimplementing techniques to improve the performance of surgicaloperations. Various surgical instruments 7012 and/or surgical hubs 7006may comprise touch-controlled user interfaces such that clinicians maycontrol aspects of interaction between the surgical instruments 7012 andthe cloud 7004. Other suitable user interfaces for control such asauditory controlled user interfaces can also be used.

FIG. 12 is a block diagram which illustrates the functional architectureof the computer-implemented interactive surgical system, in accordancewith at least one aspect of the present disclosure. The cloud-basedanalytics system may include a plurality of data analytics modules 7034that may be executed by the processors 7008 of the cloud 7004 forproviding data analytic solutions to problems specifically arising inthe medical field. As shown in FIG. 12, the functions of the cloud-baseddata analytics modules 7034 may be assisted via hub applications 7014hosted by the hub application servers 7002 that may be accessed onsurgical hubs 7006. The cloud processors 7008 and hub applications 7014may operate in conjunction to execute the data analytics modules 7034.Application program interfaces (APIs) 7016 may define the set ofprotocols and routines corresponding to the hub applications 7014.Additionally, the APIs 7016 may manage the storing and retrieval of datainto and from the aggregated medical databases 7012 for the operationsof the applications 7014. The caches 7018 may also store data (e.g.,temporarily) and may be coupled to the APIs 7016 for more efficientretrieval of data used by the applications 7014. The data analyticsmodules 7034 in FIG. 12 may include modules for resource optimization7020, data collection and aggregation 7022, authorization and security7024, control program updating 7026, patient outcome analysis 7028,recommendations 7030, and data sorting and prioritization 7032. Othersuitable data analytics modules could also be implemented by the cloud7004, according to some aspects. In one aspect, the data analyticsmodules may be used for specific recommendations based on analyzingtrends, outcomes, and other data.

For example, the data collection and aggregation module 7022 could beused to generate self-describing data (e.g., metadata) includingidentification of notable features or configuration (e.g., trends),management of redundant data sets, and storage of the data in paireddata sets which can be grouped by surgery but not necessarily keyed toactual surgical dates and surgeons. In particular, pair data setsgenerated from operations of surgical instruments 7012 can compriseapplying a binary classification, e.g., a bleeding or a non-bleedingevent. More generally, the binary classification may be characterized aseither a desirable event (e.g., a successful surgical procedure) or anundesirable event (e.g., a misfired or misused surgical instrument7012). The aggregated self-describing data may correspond to individualdata received from various groups or subgroups of surgical hubs 7006.Accordingly, the data collection and aggregation module 7022 cangenerate aggregated metadata or other organized data based on raw datareceived from the surgical hubs 7006. To this end, the processors 7008can be operationally coupled to the hub applications 7014 and aggregatedmedical data databases 7011 for executing the data analytics modules7034. The data collection and aggregation module 7022 may store theaggregated organized data into the aggregated medical data databases2212.

The resource optimization module 7020 can be configured to analyze thisaggregated data to determine an optimal usage of resources for aparticular or group of healthcare facilities. For example, the resourceoptimization module 7020 may determine an optimal order point ofsurgical stapling instruments 7012 for a group of healthcare facilitiesbased on corresponding predicted demand of such instruments 7012. Theresource optimization module 7020 might also assess the resource usageor other operational configurations of various healthcare facilities todetermine whether resource usage could be improved. Similarly, therecommendations module 7030 can be configured to analyze aggregatedorganized data from the data collection and aggregation module 7022 toprovide recommendations. For example, the recommendations module 7030could recommend to healthcare facilities (e.g., medical serviceproviders such as hospitals) that a particular surgical instrument 7012should be upgraded to an improved version based on a higher thanexpected error rate, for example. Additionally, the recommendationsmodule 7030 and/or resource optimization module 7020 could recommendbetter supply chain parameters such as product reorder points andprovide suggestions of different surgical instrument 7012, uses thereof,or procedure steps to improve surgical outcomes. The healthcarefacilities can receive such recommendations via corresponding surgicalhubs 7006. More specific recommendations regarding parameters orconfigurations of various surgical instruments 7012 can also beprovided. Hubs 7006 and/or surgical instruments 7012 each could alsohave display screens that display data or recommendations provided bythe cloud 7004.

The patient outcome analysis module 7028 can analyze surgical outcomesassociated with currently used operational parameters of surgicalinstruments 7012. The patient outcome analysis module 7028 may alsoanalyze and assess other potential operational parameters. In thisconnection, the recommendations module 7030 could recommend using theseother potential operational parameters based on yielding better surgicaloutcomes, such as better sealing or less bleeding. For example, therecommendations module 7030 could transmit recommendations to a surgical7006 regarding when to use a particular cartridge for a correspondingstapling surgical instrument 7012. Thus, the cloud-based analyticssystem, while controlling for common variables, may be configured toanalyze the large collection of raw data and to provide centralizedrecommendations over multiple healthcare facilities (advantageouslydetermined based on aggregated data). For example, the cloud-basedanalytics system could analyze, evaluate, and/or aggregate data based ontype of medical practice, type of patient, number of patients,geographic similarity between medical providers, which medicalproviders/facilities use similar types of instruments, etc., in a waythat no single healthcare facility alone would be able to analyzeindependently. The control program updating module 7026 could beconfigured to implement various surgical instrument 7012 recommendationswhen corresponding control programs are updated. For example, thepatient outcome analysis module 7028 could identify correlations linkingspecific control parameters with successful (or unsuccessful) results.Such correlations may be addressed when updated control programs aretransmitted to surgical instruments 7012 via the control programupdating module 7026. Updates to instruments 7012 that may betransmitted via a corresponding hub 7006 may incorporate aggregatedperformance data that was gathered and analyzed by the data collectionand aggregation module 7022 of the cloud 7004. Additionally, the patientoutcome analysis module 7028 and recommendations module 7030 couldidentify improved methods of using instruments 7012 based on aggregatedperformance data.

The cloud-based analytics system may include security featuresimplemented by the cloud 7004. These security features may be managed bythe authorization and security module 7024. Each surgical hub 7006 canhave associated unique credentials such as username, password, and othersuitable security credentials. These credentials could be stored in thememory 7010 and be associated with a permitted cloud access level. Forexample, based on providing accurate credentials, a surgical hub 7006may be granted access to communicate with the cloud to a predeterminedextent (e.g., may only engage in transmitting or receiving certaindefined types of information). To this end, the aggregated medical datadatabases 7011 of the cloud 7004 may comprise a database of authorizedcredentials for verifying the accuracy of provided credentials.Different credentials may be associated with varying levels ofpermission for interaction with the cloud 7004, such as a predeterminedaccess level for receiving the data analytics generated by the cloud7004. Furthermore, for security purposes, the cloud could maintain adatabase of hubs 7006, instruments 7012, and other devices that maycomprise a “black list” of prohibited devices. In particular, a surgicalhubs 7006 listed on the black list may not be permitted to interact withthe cloud, while surgical instruments 7012 listed on the black list maynot have functional access to a corresponding hub 7006 and/or may beprevented from fully functioning when paired to its corresponding hub7006. Additionally, or alternatively, the cloud 7004 may flaginstruments 7012 based on incompatibility or other specified criteria.In this manner, counterfeit medical devices and improper reuse of suchdevices throughout the cloud-based analytics system can be identifiedand addressed.

The surgical instruments 7012 may use wireless transceivers to transmitwireless signals that may represent, for example, authorizationcredentials for access to corresponding hubs 7006 and the cloud 7004.Wired transceivers may also be used to transmit signals. Suchauthorization credentials can be stored in the respective memory devicesof the surgical instruments 7012. The authorization and security module7024 can determine whether the authorization credentials are accurate orcounterfeit. The authorization and security module 7024 may alsodynamically generate authorization credentials for enhanced security.The credentials could also be encrypted, such as by using hash-basedencryption. Upon transmitting proper authorization, the surgicalinstruments 7012 may transmit a signal to the corresponding hubs 7006and ultimately the cloud 7004 to indicate that the instruments 7012 areready to obtain and transmit medical data. In response, the cloud 7004may transition into a state enabled for receiving medical data forstorage into the aggregated medical data databases 7011. This datatransmission readiness could be indicated by a light indicator on theinstruments 7012, for example. The cloud 7004 can also transmit signalsto surgical instruments 7012 for updating their associated controlprograms. The cloud 7004 can transmit signals that are directed to aparticular class of surgical instruments 7012 (e.g., electrosurgicalinstruments) so that software updates to control programs are onlytransmitted to the appropriate surgical instruments 7012. Moreover, thecloud 7004 could be used to implement system wide solutions to addresslocal or global problems based on selective data transmission andauthorization credentials. For example, if a group of surgicalinstruments 7012 are identified as having a common manufacturing defect,the cloud 7004 may change the authorization credentials corresponding tothis group to implement an operational lockout of the group.

The cloud-based analytics system may allow for monitoring multiplehealthcare facilities (e.g., medical facilities like hospitals) todetermine improved practices and recommend changes (via therecommendations module 2030, for example) accordingly. Thus, theprocessors 7008 of the cloud 7004 can analyze data associated with anindividual healthcare facility to identify the facility and aggregatethe data with other data associated with other healthcare facilities ina group. Groups could be defined based on similar operating practices orgeographical location, for example. In this way, the cloud 7064 mayprovide healthcare facility group wide analysis and recommendations. Thecloud-based analytics system could also be used for enhanced situationalawareness. For example, the processors 7008 may predictively model theeffects of recommendations on the cost and effectiveness for aparticular facility (relative to overall operations and/or variousmedical procedures). The cost and effectiveness associated with thatparticular facility can also be compared to a corresponding local regionof other facilities or any other comparable facilities.

The data sorting and prioritization module 7032 may prioritize and sortdata based on criticality (e.g., the severity of a medical eventassociated with the data, unexpectedness, suspiciousness). This sortingand prioritization may be used in conjunction with the functions of theother data analytics modules 7034 described herein to improve thecloud-based analytics and operations described herein. For example, thedata sorting and prioritization module 7032 can assign a priority to thedata analysis performed by the data collection and aggregation module7022 and patient outcome analysis modules 7028. Different prioritizationlevels can result in particular responses from the cloud 7004(corresponding to a level of urgency) such as escalation for anexpedited response, special processing, exclusion from the aggregatedmedical data databases 7011, or other suitable responses. Moreover, ifnecessary, the cloud 704 can transmit a request (e.g., a push message)through the hub application servers for additional data fromcorresponding surgical instruments 7012. The push message can result ina notification displayed on the corresponding hubs 7006 for requestingsupporting or additional data. This push message may be required insituations in which the cloud detects a significant irregularity oroutlier and the cloud cannot determine the cause of the irregularity.The central servers 7013 may be programmed to trigger this push messagein certain significant circumstances, such as when data is determined tobe different from an expected value beyond a predetermined threshold orwhen it appears security has been comprised, for example.

Additional example details for the various functions described areprovided in the ensuing descriptions below. Each of the variousdescriptions may utilize the cloud architecture as described in FIGS. 11and 12 as one example of hardware and software implementation.

FIG. 13 illustrates a block diagram of a computer-implemented adaptivesurgical system 9060 that is configured to adaptively generate controlprogram updates for modular devices 9050, in accordance with at leastone aspect of the present disclosure. In some exemplifications, thesurgical system may include a surgical hub 9000, multiple modulardevices 9050 communicably coupled to the surgical hub 9000, and ananalytics system 9100 communicably coupled to the surgical hub 9000.Although a single surgical hub 9000 may be depicted, it should be notedthat the surgical system 9060 can include any number of surgical hubs9000, which can be connected to form a network of surgical hubs 9000that are communicably coupled to the analytics system 9010. In someexemplifications, the surgical hub 9000 may include a processor 9010coupled to a memory 9020 for executing instructions stored thereon and adata relay interface 9030 through which data is transmitted to theanalytics system 9100. In some exemplifications, the surgical hub 9000further may include a user interface 9090 having an input device 9092(e.g., a capacitive touchscreen or a keyboard) for receiving inputs froma user and an output device 9094 (e.g., a display screen) for providingoutputs to a user. Outputs can include data from a query input by theuser, suggestions for products or mixes of products to use in a givenprocedure, and/or instructions for actions to be carried out before,during, or after surgical procedures. The surgical hub 9000 further mayinclude an interface 9040 for communicably coupling the modular devices9050 to the surgical hub 9000. In one aspect, the interface 9040 mayinclude a transceiver that is communicably connectable to the modulardevice 9050 via a wireless communication protocol. The modular devices9050 can include, for example, surgical stapling and cuttinginstruments, electrosurgical instruments, ultrasonic instruments,insufflators, respirators, and display screens. In someexemplifications, the surgical hub 9000 can further be communicablycoupled to one or more patient monitoring devices 9052, such as EKGmonitors or BP monitors. In some exemplifications, the surgical hub 9000can further be communicably coupled to one or more databases 9054 orexternal computer systems, such as an EMR database of the medicalfacility at which the surgical hub 9000 is located.

When the modular devices 9050 are connected to the surgical hub 9000,the surgical hub 9000 can sense or receive perioperative data from themodular devices 9050 and then associate the received perioperative datawith surgical procedural outcome data. The perioperative data mayindicate how the modular devices 9050 were controlled during the courseof a surgical procedure. The procedural outcome data includes dataassociated with a result from the surgical procedure (or a stepthereof), which can include whether the surgical procedure (or a stepthereof) had a positive or negative outcome. For example, the outcomedata could include whether a patient suffered from postoperativecomplications from a particular procedure or whether there was leakage(e.g., bleeding or air leakage) at a particular staple or incision line.The surgical hub 9000 can obtain the surgical procedural outcome data byreceiving the data from an external source (e.g., from an EMR database9054), by directly detecting the outcome (e.g., via one of the connectedmodular devices 9050), or inferring the occurrence of the outcomesthrough a situational awareness system. For example, data regardingpostoperative complications could be retrieved from an EMR database 9054and data regarding staple or incision line leakages could be directlydetected or inferred by a situational awareness system. The surgicalprocedural outcome data can be inferred by a situational awarenesssystem from data received from a variety of data sources, including themodular devices 9050 themselves, the patient monitoring device 9052, andthe databases 9054 to which the surgical hub 9000 is connected.

The surgical hub 9000 can transmit the associated modular device 9050data and outcome data to the analytics system 9100 for processingthereon. By transmitting both the perioperative data indicating how themodular devices 9050 are controlled and the procedural outcome data, theanalytics system 9100 can correlate the different manners of controllingthe modular devices 9050 with surgical outcomes for the particularprocedure type. In some exemplifications, the analytics system 9100 mayinclude a network of analytics servers 9070 that are configured toreceive data from the surgical hubs 9000. Each of the analytics servers9070 can include a memory and a processor coupled to the memory that isexecuting instructions stored thereon to analyze the received data. Insome exemplifications, the analytics servers 9070 may be connected in adistributed computing architecture and/or utilize a cloud computingarchitecture. Based on this paired data, the analytics system 9100 canthen learn optimal or preferred operating parameters for the varioustypes of modular devices 9050, generate adjustments to the controlprograms of the modular devices 9050 in the field, and then transmit (or“push”) updates to the modular devices' 9050 control programs.

Additional detail regarding the computer-implemented interactivesurgical system 9060, including the surgical hub 9000 and variousmodular devices 9050 connectable thereto, are described in connectionwith FIGS. 5-6.

FIG. 14 provides a surgical system 6500 in accordance with the presentdisclosure and may include a surgical instrument 6502 that can be incommunication with a console 6522 or a portable device 6526 through alocal area network 6518 or a cloud network 6520 via a wired or wirelessconnection. In various aspects, the console 6522 and the portable device6526 may be any suitable computing device. The surgical instrument 6502may include a handle 6504, an adapter 6508, and a loading unit 6514. Theadapter 6508 releasably couples to the handle 6504 and the loading unit6514 releasably couples to the adapter 6508 such that the adapter 6508transmits a force from a drive shaft to the loading unit 6514. Theadapter 6508 or the loading unit 6514 may include a force gauge (notexplicitly shown) disposed therein to measure a force exerted on theloading unit 6514. The loading unit 6514 may include an end effector6530 having a first jaw 6532 and a second jaw 6534. The loading unit6514 may be an in-situ loaded or multi-firing loading unit (MFLU) thatallows a clinician to fire a plurality of fasteners multiple timeswithout requiring the loading unit 6514 to be removed from a surgicalsite to reload the loading unit 6514.

The first and second jaws 6532, 6534 may be configured to clamp tissuetherebetween, fire fasteners through the clamped tissue, and sever theclamped tissue. The first jaw 6532 may be configured to fire at leastone fastener a plurality of times, or may be configured to include areplaceable multi-fire fastener cartridge including a plurality offasteners (e.g., staples, clips, etc.) that may be fired more than onetime prior to being replaced. The second jaw 6534 may include an anvilthat deforms or otherwise secures the fasteners about tissue as thefasteners are ejected from the multi-fire fastener cartridge.

The handle 6504 may include a motor that is coupled to the drive shaftto affect rotation of the drive shaft. The handle 6504 may include acontrol interface to selectively activate the motor. The controlinterface may include buttons, switches, levers, sliders, touchscreen,and any other suitable input mechanisms or user interfaces, which can beengaged by a clinician to activate the motor.

The control interface of the handle 6504 may be in communication with acontroller 6528 of the handle 6504 to selectively activate the motor toaffect rotation of the drive shafts. The controller 6528 may be disposedwithin the handle 6504 and is configured to receive input from thecontrol interface and adapter data from the adapter 6508 or loading unitdata from the loading unit 6514. The controller 6528 may analyze theinput from the control interface and the data received from the adapter6508 and/or loading unit 6514 to selectively activate the motor. Thehandle 6504 may also include a display that is viewable by a clinicianduring use of the handle 6504. The display may be configured to displayportions of the adapter or loading unit data before, during, or afterfiring of the instrument 6502.

The adapter 6508 may include an adapter identification device 6510disposed therein and the loading unit 6514 includes a loading unitidentification device 6516 disposed therein. The adapter identificationdevice 6510 may be in communication with the controller 6528, and theloading unit identification device 6516 may be in communication with thecontroller 6528. It will be appreciated that the loading unitidentification device 6516 may be in communication with the adapteridentification device 6510, which relays or passes communication fromthe loading unit identification device 6516 to the controller 6528.

The adapter 6508 may also include a plurality of sensors 6512 (oneshown) disposed thereabout to detect various conditions of the adapter6508 or of the environment (e.g., if the adapter 6508 is connected to aloading unit, if the adapter 6508 is connected to a handle, if the driveshafts are rotating, the torque of the drive shafts, the strain of thedrive shafts, the temperature within the adapter 6508, a number offirings of the adapter 6508, a peak force of the adapter 6508 duringfiring, a total amount of force applied to the adapter 6508, a peakretraction force of the adapter 6508, a number of pauses of the adapter6508 during firing, etc.). The plurality of sensors 6512 may provide aninput to the adapter identification device 6510 in the form of datasignals. The data signals of the plurality of sensors 6512 may be storedwithin, or be used to update the adapter data stored within, the adapteridentification device 6510. The data signals of the plurality of sensors6512 may be analog or digital. The plurality of sensors 6512 may includea force gauge to measure a force exerted on the loading unit 6514 duringfiring.

The handle 6504 and the adapter 6508 can be configured to interconnectthe adapter identification device 6510 and the loading unitidentification device 6516 with the controller 6528 via an electricalinterface. The electrical interface may be a direct electrical interface(i.e., include electrical contacts that engage one another to transmitenergy and signals therebetween). Additionally or alternatively, theelectrical interface may be a non-contact electrical interface towirelessly transmit energy and signals therebetween (e.g., inductivelytransfer). It is also contemplated that the adapter identificationdevice 6510 and the controller 6528 may be in wireless communicationwith one another via a wireless connection separate from the electricalinterface.

The handle 6504 may include a transmitter 6506 that is configured totransmit instrument data from the controller 6528 to other components ofthe system 6500 (e.g., the LAN 6518, the cloud 6520, the console 6522,or the portable device 6526). The transmitter 6506 also may receive data(e.g., cartridge data, loading unit data, or adapter data) from theother components of the system 6500. For example, the controller 6528may transmit instrument data including a serial number of an attachedadapter (e.g., adapter 6508) attached to the handle 6504, a serialnumber of a loading unit (e.g., loading unit 6514) attached to theadapter, and a serial number of a multi-fire fastener cartridge (e.g.,multi-fire fastener cartridge), loaded into the loading unit, to theconsole 6528. Thereafter, the console 6522 may transmit data (e.g.,cartridge data, loading unit data, or adapter data) associated with theattached cartridge, loading unit, and adapter, respectively, back to thecontroller 6528. The controller 6528 can display messages on the localinstrument display or transmit the message, via transmitter 6506, to theconsole 6522 or the portable device 6526 to display the message on thedisplay 6524 or portable device screen, respectively.

FIG. 15A illustrates an example flow for determining a mode of operationand operating in the determined mode. The computer-implementedinteractive surgical system and/or components and/or subsystems of thecomputer-implemented interactive surgical system may be configured to beupdated. Such updates may include the inclusions of features andbenefits that were not available to the user before the update. Theseupdates may be established by any method of hardware, firmware, andsoftware updates suitable for introducing the feature to the user. Forexample, replaceable/swappable (e.g., hot swappable) hardwarecomponents, flashable firmware devices, and updatable software systemsmay be used to update computer-implemented interactive surgical systemand/or components and/or subsystems of the computer-implementedinteractive surgical system.

The updates may be conditioned on any suitable criterion or set ofcriteria. For example, an update may be conditioned on one or morehardware capabilities of the system, such as processing capability,bandwidth, resolution, and the like. For example, the update may beconditioned on one or more software aspects, such as a purchase ofcertain software code. For example, the update may be conditioned on apurchased service tier. The service tier may represent a feature and/ora set of features the user is entitled to use in connection with thecomputer-implemented interactive surgical system. The service tier maybe determined by a license code, an e-commerce server authenticationinteraction, a hardware key, a username/password combination, abiometric authentication interaction, a public/private key exchangeinteraction, or the like.

At 10704, a system/device parameter may be identified. The system/deviceparameter may be any element or set of elements on which an update inconditioned. For example, the computer-implemented interactive surgicalsystem may detect a certain bandwidth of communication between a modulardevice and a surgical hub. For example, the computer-implementedinteractive surgical system may detect an indication of the purchase ofcertain service tier.

At 10708, a mode of operation may be determined based on the identifiedsystem/device parameter. This determination may be made by a processthat maps system/device parameters to modes of operation. The processmay be a manual and/or an automated process. The process may be theresult of local computation and/or remote computation. For example, aclient/server interaction may be used to determine the mode of operationbased on the on the identified system/device parameter. For example,local software and/or locally embedded firmware may be used to determinethe mode of operation based on the identified system/device parameter.For example, a hardware key, such as a secure microprocessor forexample, may be used to determine the mode of operation based on theidentified system/device parameter.

At 10710, operation may proceed in accordance with the determined modeof operation. For example, a system or device may proceed to operate ina default mode of operation. For example, a system or device may proceedto operate in an alternate mode of operation. The mode of operation maybe directed by control hardware, firmware, and/or software alreadyresident in the system or device. The mode of operation may be directedby control hardware, firmware, and/or software newly installed/updated.

FIG. 15B illustrates an example functional block diagram for changing amode of operation. An upgradeable element 10714 may include aninitialization component 10716. The initialization component 10716 mayinclude any hardware, firmware, and/or software suitable determining amode of operation. For example, the initialization component 10716 maybe portion of a system or device start-up procedure. The initializationcomponent 10716 may engage in an interaction to determine a mode ofoperation for the upgradeable element 10714. For example, theinitialization component 10716 may interact with a user 10730, anexternal resource 10732, and/or a local resource 10718 for example. Forexample, the initialization component 10716 may receive a licensing keyfrom the user 10730 to determine a mode of operation. The initializationcomponent 10716 may query an external resource 10732, such as a serverfor example, with a serial number of the upgradable device 10714 todetermine a mode of operation. For example, the initialization component10716 may query a local resource 10718, such as a local query todetermine an amount of available bandwidth and/or a local query of ahardware key for example, to determine a mode of operation.

The upgradeable element 10714 may include one or more operationcomponents 10720, 10722, 10726, 10728 and an operational pointer 10724.The initialization component 10716 may direct the operational pointer10724 to direct the operation of the upgradable element 10741 to theoperation component 10720, 10722, 10726, 10728 that corresponds with thedetermined mode of operation. The initialization component 10716 maydirect the operational pointer 10724 to direct the operation of theupgradable element to a default operation component 10720. For example,the default operation component 10720 may be selected on the conditionof no other alternate mode of operation being determined. For example,the default operation component 10720 may be selected on the conditionof a failure of the initialization component and/or interaction failure.The initialization component 10716 may direct the operational pointer10724 to direct the operation of the upgradable element 10714 to aresident operation component 10722. For example, certain features may beresident in the upgradable component 10714 but require activation to beput into operation. The initialization component 10716 may direct theoperational pointer 10724 to direct the operation of the upgradableelement 10714 to install a new operation component 10728 and/or a newinstalled operation component 10726. For example, new software and/orfirmware may be downloaded. The new software and or firmware may containcode to enable the features represented by the selected mode ofoperation. For example, a new hardware component may be installed toenable the selected mode of operation.

FIG. 16 is a perspective view of a surgical instrument 150010 that hasan interchangeable shaft assembly 150200 operably coupled thereto, inaccordance with at least one aspect of this disclosure. The housing150012 includes an end effector 150300 that comprises a surgical cuttingand fastening device configured to operably support a surgical staplecartridge 150304 therein. The housing 150012 may be configured for usein connection with interchangeable shaft assemblies that include endeffectors that are adapted to support different sizes and types ofstaple cartridges, have different shaft lengths, sizes, and types. Thehousing 150012 may be employed with a variety of interchangeable shaftassemblies, including assemblies configured to apply other motions andforms of energy such as, radio frequency (RF) energy, ultrasonic energy,and/or motion to end effector arrangements adapted for use in connectionwith various surgical applications and procedures. The end effectors,shaft assemblies, handles, surgical instruments, and/or surgicalinstrument systems can utilize any suitable fastener, or fasteners, tofasten tissue. For instance, a fastener cartridge comprising a pluralityof fasteners removably stored therein can be removably inserted intoand/or attached to the end effector of a shaft assembly.

The handle assembly 150014 may comprise a pair of interconnectablehandle housing segments 150016, 150018 interconnected by screws, snapfeatures, adhesive, etc. The handle housing segments 150016, 150018cooperate to form a pistol grip portion 150019 that can be gripped andmanipulated by the clinician. The handle assembly 150014 operablysupports a plurality of drive systems configured to generate and applycontrol motions to corresponding portions of the interchangeable shaftassembly that is operably attached thereto. A display may be providedbelow a cover 150045.

FIG. 17 is an exploded assembly view of a portion of the surgicalinstrument 150010 of FIG. 16, in accordance with at least one aspect ofthis disclosure. The handle assembly 150014 may include a frame 150020that operably supports a plurality of drive systems. The frame 150020can operably support a “first” or closure drive system 150030, which canapply closing and opening motions to the interchangeable shaft assembly150200. The closure drive system 150030 may include an actuator such asa closure trigger 150032 pivotally supported by the frame 150020. Theclosure trigger 150032 is pivotally coupled to the handle assembly150014 by a pivot pin 150033 to enable the closure trigger 150032 to bemanipulated by a clinician. When the clinician grips the pistol gripportion 150019 of the handle assembly 150014, the closure trigger 150032can pivot from a starting or “unactuated” position to an “actuated”position and more particularly to a fully compressed or fully actuatedposition.

The handle assembly 150014 and the frame 150020 may operably support afiring drive system 150080 configured to apply firing motions tocorresponding portions of the interchangeable shaft assembly attachedthereto. The firing drive system 150080 may employ an electric motor150082 located m the pistol grip portion 150019 of the handle assembly150014. The electric motor 150082 may be a DC brushed motor having amaximum rotational speed of approximately 25,000 RPM, for example. Inother arrangements, the motor may include a brushless motor, a cordlessmotor, a synchronous motor, a stepper motor, or any other suitableelectric motor. The electric motor 150082 may be powered by a powersource 150090 that may comprise a removable power pack 150092. Theremovable power pack 150092 may comprise a proximal housing portion150094 configured to attach to a distal housing portion 150096. Theproximal housing portion 150094 and the distal housing portion 150096are configured to operably support a plurality of batteries 150098therein. Batteries 150098 may each comprise, for example, a Lithium Ion(LI) or other suitable battery. The distal housing portion 150096 isconfigured for removable operable attachment to a control circuit board150100, which is operably coupled to the electric motor 150082. Severalbatteries 150098 connected in series may power the surgical instrument150010. The power source 150090 may be replaceable and/or rechargeable.A display 150043, which is located below the cover 150045, iselectrically coupled to the control circuit board 150100. The cover150045 may be removed to expose the display 150043.

The electric motor 150082 can include a rotatable shaft (not shown) thatoperably interfaces with a gear reducer assembly 150084 mounted inmeshing engagement with a set, or rack, of drive teeth 150122 on alongitudinally movable drive member 150120. The longitudinally movabledrive member 150120 has a rack of drive teeth 150122 formed thereon formeshing engagement with a corresponding drive gear 150086 of the gearreducer assembly 150084. In use, a voltage polarity provided by thepower source 150090 can operate the electric motor 150082 in a clockwisedirection wherein the voltage polarity applied to the electric motor bythe battery can be reversed in order to operate the electric motor150082 in a counter-clockwise direction. When the electric motor 150082is rotated in one direction, the longitudinally movable drive member150120 will be axially driven in the distal direction “DD.” When theelectric motor 150082 is driven in the opposite rotary direction, thelongitudinally movable drive member 150120 will be axially driven in aproximal direction “PD.” The handle assembly 150014 can include a switchthat can be configured to reverse the polarity applied to the electricmotor 150082 by the power source 150090. The handle assembly 150014 mayinclude a sensor configured to detect the position of the longitudinallymovable drive member 150120 and/or the direction in which thelongitudinally movable drive member 150120 is being moved.

Actuation of the electric motor 150082 can be controlled by a firingtrigger 150130 that is pivotally sup-ported on the handle assembly150014. The firing trigger 150130 may be pivoted between an unactuatedposition and an actuated position.

Turning back to FIG. 16, the interchangeable shaft assembly 150200includes an end effector 150300 comprising an elongated channel 150302configured to operably support a surgical staple cartridge 150304therein. The end effector 150300 may include an anvil 150306 that ispivotally supported relative to the elongated channel 150302. Theinterchangeable shaft assembly 150200 may include an articulation joint150270. Construction and operation of the end effector 15030 and thearticulation joint 150270 are set forth in U.S. Patent ApplicationPublication No. 2014/0263541, titled ARTICULATABLE SURGICAL INSTRUMENTCOMPRISING AN ARTICULATION LOCK, which is herein incorporated byreference in its entirety. The interchangeable shaft assembly 150200 mayinclude a proximal housing or nozzle 150201 comprised of nozzle portions150202, 150203. The interchangeable shaft assembly 150200 may include aclosure tube 150260 extending along a shaft axis SA that can be utilizedto close and/or open the anvil 150306 of the end effector 150300.Turning back to FIG. 16, the closure tube 150260 is translated distally(direction “DD”) to close the anvil 150306, for example, in response tothe actuation of the closure trigger 150032 in the manner described inthe aforementioned reference U.S. Patent Application Publication No.2014/0263541. The anvil 150306 is opened by proximally translating theclosure tube 150260. In the anvil open position, the closure tube 150260is moved to its proximal position.

FIG. 18 is another exploded assembly view of portions of theinterchangeable shaft assembly 150200, in accordance with at least oneaspect of this disclosure. The interchangeable shaft assembly 150200 mayinclude a firing member 150220 supported for axial travel within thespine 150210. The firing member 150220 includes an intermediate firingshaft 150222 configured to attach to a distal cutting portion or knifebar 150280. The firing member 150220 may be referred to as a “secondshaft” or a “second shaft assembly”. The intermediate firing shaft150222 may include a longitudinal slot 150223 in a distal end configuredto receive a tab 150284 on the proximal end 150282 of the knife bar150280. The longitudinal slot 150223 and the proximal end 150282 may beconfigured to permit relative movement there between and can comprise aslip joint 150286. The slip joint 150286 can permit the intermediatefiring shaft 150222 of the firing member 150220 to articulate the endeffector 150300 about the articulation joint 150270 without moving, orat least substantially moving, the knife bar 150280. Once the endeffector 150300 has been suitably oriented, the intermediate firingshaft 150222 can be advanced distally until a proximal sidewall of thelongitudinal slot 150223 contacts the tab 150284 to advance the knifebar 150280 and fire the staple cartridge positioned within the channel150302. The spine 150210 has an elongated opening or window 150213therein to facilitate assembly and insertion of the intermediate firingshaft 150222 into the spine 150210. Once the intermediate firing shaft150222 has been inserted therein, a top frame segment 150215 may beengaged with the shaft frame 150212 to enclose the intermediate firingshaft 150222 and knife bar 150280 therein. Operation of the firingmember 150220 may be found in U.S. Patent Application Publication No.2014/0263541. A spine 150210 can be configured to slidably support afiring member 150220 and the closure tube 150260 that extends around thespine 150210. The spine 150210 may slidably support an articulationdriver 150230.

The interchangeable shaft assembly 150200 can include a clutch assembly150400 configured to selectively and releasably couple the articulationdriver 150230 to the firing member 150220. The clutch assembly 150400includes a lock collar, or lock sleeve 150402, positioned around thefiring member 150220 wherein the lock sleeve 150402 can be rotatedbetween an engaged position in which the lock sleeve 150402 couples thearticulation driver 150230 to the firing member 150220 and a disengagedposition in which the articulation driver 150230 is not operably coupledto the firing member 150220. When the lock sleeve 150402 is in theengaged position, distal movement of the firing member 150220 can movethe articulation driver 150230 distally and, correspondingly, proximalmovement of the firing member 150220 can move the articulation driver150230 proximally. When the lock sleeve 150402 is in the disengagedposition, movement of the firing member 150220 is not transmitted to thearticulation driver 150230 and, as a result, the firing member 150220can move independently of the articulation driver 150230. The nozzle150201 may be employed to operably engage and disengage the articulationdrive system with the firing drive system in the various mannersdescribed in U.S. Patent Application Publication No. 2014/0263541.

The interchangeable shaft assembly 150200 can comprise a slip ringassembly 150600 which can be configured to conduct electrical power toand/or from the end effector 150300 and/or communicate signals to and/orfrom the end effector 150300, for example. The slip ring assembly 150600can comprise a proximal connector flange 150604 and a distal connectorflange 150601 positioned within a slot defined in the nozzle portions150202, 150203. The proximal connector flange 150604 can comprise afirst face and the distal connector flange 150601 can comprise a secondface positioned adjacent to and movable relative to the first face. Thedistal connector flange 150601 can rotate relative to the proximalconnector flange 150604 about the shaft axis SA-SA. The proximalconnector flange 150604 can comprise a plurality of concentric, or atleast substantially concentric, conductors 150602 defined in the firstface thereof. A connector 150607 can be mounted on the proximal side ofthe distal connector flange 150601 and may have a plurality of contactswherein each contact corresponds to and is in electrical contact withone of the conductors 150602. Such an arrangement permits relativerotation between the proximal connector flange 150604 and the distalconnector flange 150601 while maintaining electrical contact therebetween. The proximal connector flange 150604 can include an electricalconnector 150606 that can place the conductors 150602 in signalcommunication with a shaft circuit board, for example. In at least oneinstance, a wiring harness comprising a plurality of conductors canextend between the electrical connector 150606 and the shaft circuitboard. The electrical connector 150606 may extend proximally through aconnector opening defined in the chassis mounting flange. U.S. PatentApplication Publication No. 2014/0263551, titled STAPLE CARTRIDGE TISSUETHICKNESS SENSOR SYSTEM, is incorporated herein by reference in itsentirety. U.S. Patent Application Publication No. 2014/0263552, titledSTAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM, is incorporated byreference in its entirety. Further details regarding slip ring assembly150600 may be found in U.S. Patent Application Publication No.2014/0263541.

The interchangeable shaft assembly 150200 can include a proximal portionfixably mounted to the handle assembly 150014 and a distal portion thatis rotatable about a longitudinal axis. The rotatable distal shaftportion can be rotated relative to the proximal portion about the slipring assembly 150600. The distal connector flange 150601 of the slipring assembly 150600 can be positioned within the rotatable distal shaftportion.

FIG. 19 is an exploded view of one aspect of an end effector 150300 ofthe surgical instrument 150010 of FIG. 16, in accordance with at leastone aspect of this disclosure. The end effector 150300 may include theanvil 150306 and the surgical staple cartridge 150304. The anvil 150306may be coupled to an elongated channel 150302. Apertures 150199 can bedefined in the elongated channel 150302 to receive pins 150152 extendingfrom the anvil 150306 to allow the anvil 150306 to pivot from an openposition to a closed position relative to the elongated channel 150302and surgical staple cartridge 150304. A firing bar 150172 is configuredto longitudinally translate into the end effector 150300. The firing bar150172 may be constructed from one solid section, or may include alaminate material comprising a stack of steel plates. The firing bar150172 comprises an I-beam 150178 and a cutting edge 150182 at a distalend thereof. A distally projecting end of the firing bar 150172 can beattached to the I-beam 150178 to assist in spacing the anvil 150306 froma surgical staple cartridge 150304 positioned in the elongated channel150302 when the anvil 150306 is in a closed position. The I-beam 150178may include a sharpened cutting edge 150182 to sever tissue as theI-beam 150178 is advanced distally by the firing bar 150172. Inoperation, the I-beam 150178 may, or fire, the surgical staple cartridge150304. The surgical staple cartridge 150304 can include a moldedcartridge body 150194 that holds a plurality of staples 150191 restingupon staple drivers 150192 within respective upwardly open staplecavities 150195. A wedge sled 150190 is driven distally by the I-beam150178, sliding upon a cartridge tray 150196 of the surgical staplecartridge 150304. The wedge sled 150190 upwardly cams the staple drivers150192 to force out the staples 150191 into deforming contact with theanvil 150306 while the cutting edge 150182 of the I-beam 150178 seversclamped tissue.

The I-beam 150178 can include upper pins 150180 that engage the anvil150306 during firing. The I-beam 150178 may include middle pins 150184and a bottom foot 150186 to engage portions of the cartridge body150194, cartridge tray 150196, and elongated channel 150302. When asurgical staple cartridge 150304 is positioned within the elongatedchannel 150302, a slot 150193 defined in the cartridge body 150194 canbe aligned with a longitudinal slot 150197 defined in the cartridge tray150196 and a slot 150189 defined in the elongated channel 150302. Inuse, the I-beam 150178 can slide through the aligned longitudinal slots150193, 150197, and 150189 wherein the bottom foot 150186 of the I-beam150178 can engage a groove running along the bottom surface of elongatedchannel 150302 along the length of slot 150189, the middle pins 150184can engage the top surfaces of cartridge tray 150196 along the length oflongitudinal slot 150197, and the upper pins 150180 can engage the anvil150306. The I-beam 150178 can space, or limit the relative movementbetween, the anvil 150306 and the surgical staple cartridge 150304 asthe firing bar 150172 is advanced distally to fire the staples from thesurgical staple cartridge 150304 and/or incise the tissue capturedbetween the anvil 150306 and the surgical staple cartridge 150304. Thefiring bar 150172 and the I-beam 150178 can be retracted proximallyallowing the anvil 150306 to be opened to release the two stapled andsevered tissue portions.

FIGS. 20A and 20B is a block diagram of a control circuit 150700 of thesurgical instrument 150010 of FIG. 16, spanning two drawing sheets, inaccordance with at least one aspect of this disclosure. Referringprimarily to FIGS. 29A and 29B, a handle assembly 150702 may include amotor 150714 which can be controlled by a motor driver 150715 and can beemployed by the firing system of the surgical instrument 150010. Invarious forms, the motor 150714 may be a DC brushed driving motor havinga maximum rotational speed of approximately 25,000 RPM. In otherarrangements, the motor 150714 may include a brushless motor, a cordlessmotor, a synchronous motor, a stepper motor, or any other suitableelectric motor. The motor driver 150715 may comprise an H-Bridge drivercomprising field effect transistors (FETs) 150719, for example. Themotor 150714 can be powered by the power assembly 150706 releasablymounted to the handle assembly 150200 for supplying control power to thesurgical instrument 150010. The power assembly 150706 may comprise abattery which may include a number of battery cells connected in seriesthat can be used as the power source to power the surgical instrument150010. In certain circumstances, the battery cells of the powerassembly 150706 may be replaceable and/or rechargeable. In at least oneexample, the battery cells can be Lithium-Ion batteries which can beseparably couplable to the power assembly 150706.

The shaft assembly 150704 may include a shaft assembly controller 150722which can communicate with a safety controller and power managementcontroller 150716 through an interface while the shaft assembly 150704and the power assembly 150706 are coupled to the handle assembly 150702.For example, the interface may comprise a first interface portion 150725which may include one or more electric connectors for couplingengagement with corresponding shaft assembly electric connectors and asecond interface portion 150727 which may include one or more electricconnectors for coupling engagement with corresponding power assemblyelectric connectors to permit electrical communication between the shaftassembly controller 150722 and the power management controller 150716while the shaft assembly 150704 and the power assembly 150706 arecoupled to the handle assembly 150702. One or more communication signalscan be transmitted through the interface to communicate one or more ofthe power requirements of the attached interchangeable shaft assembly150704 to the power management controller 150716. In response, the powermanagement controller may modulate the power output of the battery ofthe power assembly 150706, as described below in greater detail, inaccordance with the power requirements of the attached shaft assembly150704. The connectors may comprise switches which can be activatedafter mechanical coupling engagement of the handle assembly 150702 tothe shaft assembly 150704 and/or to the power assembly 150706 to allowelectrical communication between the shaft assembly controller 150722and the power management controller 150716.

The interface can facilitate transmission of the one or morecommunication signals between the power management controller 150716 andthe shaft assembly controller 150722 by routing such communicationsignals through a main controller 150717 residing in the handle assembly150702, for example. In other circumstances, the interface canfacilitate a direct line of communication between the power managementcontroller 150716 and the shaft assembly controller 150722 through thehandle assembly 150702 while the shaft assembly 150704 and the powerassembly 150706 are coupled to the handle assembly 150702.

The main controller 150717 may be any single core or multicore processorsuch as those known under the trade name ARM Cortex by TexasInstruments. In one aspect, the main controller 150717 may be anLM4F230H5QR ARM Cortex-M4F Processor Core, available from TexasInstruments, for example, comprising on-chip memory of 256 KBsingle-cycle flash memory, or other non-volatile memory, up to 40 MHz, aprefetch buffer to improve performance above 40 MHz, a 32 KBsingle-cycle serial random access memory (SRAM), internal read-onlymemory (ROM) loaded with Stellaris Ware® software, 2 KB electricallyerasable programmable read-only memory (EEPROM), one or more pulse widthmodulation (PWM) modules, one or more quadrature encoder inputs (QEI)analog, one or more 12-bit Analog-to-Digital Converters (ADC) with 12analog input channels, details of which are available for the productdatasheet. The safety controller may be a safety controller platformcomprising two controller based families such as TMS570 and RM4x knownunder the trade name Hercules ARM Cortex R4, also by Texas Instruments.The safety controller may be configured specifically for IEC 61508 andISO 26262 safety critical applications, among others, to provideadvanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The power assembly 150706 may include a power management circuit whichmay comprise the power management controller 150716, a power modulator150738, and a current sense circuit 150736. The power management circuitcan be configured to modulate power output of the battery based on thepower requirements of the shaft assembly 150704 while the shaft assembly150704 and the power assembly 150706 are coupled to the handle assembly150702. The power management controller 150716 can be programmed tocontrol the power modulator 150738 of the power output of the powerassembly 150706 and the current sense circuit 150736 can be employed tomonitor power output of the power assembly 150706 to provide feedback tothe power management controller 150716 about the power output of thebattery so that the power management controller 150716 may adjust thepower output of the power assembly 150706 to maintain a desired output.The power management controller 150716 and/or the shaft assemblycontroller 150722 each may comprise one or more processors and/or memoryunits which may store a number of software modules.

The surgical instrument 150010 (FIGS. 16 to 19) may comprise an outputdevice 150742 which may include devices for providing a sensory feedbackto a user. Such devices may comprise, for example, visual feedbackdevices (e.g., an LCD display screen, LED indicators), audio feedbackdevices (e.g., a speaker, a buzzer) or tactile feedback devices (e.g.,haptic actuators). In certain circumstances, the output device 150742may comprise a display 150743 which may be included in the handleassembly 150702. The shaft assembly controller 150722 and/or the powermanagement controller 150716 can provide feedback to a user of thesurgical instrument 150010 through the output device 150742. Theinterface can be configured to connect the shaft assembly controller150722 and/or the power management controller 150716 to the outputdevice 150742. The output device 150742 can instead be integrated withthe power assembly 150706. In such circumstances, communication betweenthe output device 150742 and the shaft assembly controller 150722 may beaccomplished through the interface while the shaft assembly 150704 iscoupled to the handle assembly 150702. The control circuit 150700comprises circuit segments configured to control operations of thepowered surgical instrument 150010. A safety controller segment (Segment1) comprises a safety controller and the main controller 150717 segment(Segment 2). The safety controller and/or the main controller 150717 areconfigured to interact with one or more additional circuit segments suchas an acceleration segment, a display segment, a shaft segment, anencoder segment, a motor segment, and a power segment. Each of thecircuit segments may be coupled to the safety controller and/or the maincontroller 150717. The main controller 150717 is also coupled to a flashmemory. The main controller 150717 also comprises a serial communicationinterface. The main controller 150717 comprises a plurality of inputscoupled to, for example, one or more circuit segments, a battery, and/ora plurality of switches. The segmented circuit may be implemented by anysuitable circuit, such as, for example, a printed circuit board assembly(PCBA) within the powered surgical instrument 150010. It should beunderstood that the term processor as used herein includes anymicroprocessor, processors, controller, controllers, or other basiccomputing device that incorporates the functions of a computer's centralprocessing unit (CPU) on an integrated circuit or at most a fewintegrated circuits. The main controller 150717 is a multipurpose,programmable device that accepts digital data as input, processes itaccording to instructions stored in its memory, and provides results asoutput. It is an example of sequential digital logic, as it has internalmemory. The control circuit 150700 can be configured to implement one ormore of the processes described herein.

The acceleration segment (Segment 3) comprises an accelerometer. Theaccelerometer is configured to detect movement or acceleration of thepowered surgical instrument 150010. Input from the accelerometer may beused to transition to and from a sleep mode, identify an orientation ofthe powered surgical instrument, and/or identify when the surgicalinstrument has been dropped. In some examples, the acceleration segmentis coupled to the safety controller and/or the main controller 150717.

The display segment (Segment 4) comprises a display connector coupled tothe main controller 150717. The display connector couples the maincontroller 150717 to a display through one or more integrated circuitdrivers of the display. The integrated circuit drivers of the displaymay be integrated with the display and/or may be located separately fromthe display. The display may comprise any suitable display, such as, forexample, an organic light emitting diode (OLED) display, aliquid-crystal display (LCD), and/or any other suitable display. In someexamples, the display segment is coupled to the safety controller.

The shaft segment (Segment 5) comprises controls for an interchangeableshaft assembly coupled to the surgical instrument 150010 and/or one ormore controls for an end effector 150300 coupled to the interchangeableshaft assembly 150200. The shaft segment comprises a shaft connectorconfigured to couple the main controller 150717 to a shaft PCBA. Theshaft PCBA comprises a low-power microcontroller with a ferroelectricrandom access memory (FRAM), an articulation switch, a shaft releaseHall effect switch, and a shaft PCBA EEPROM. The shaft PCBA EEPROMcomprises one or more parameters, routines, and/or programs specific tothe interchangeable shaft assembly 150200 and/or the shaft PCBA. Theshaft PCBA may be coupled to the interchangeable shaft assembly 150200and/or integral with the surgical instrument 150010. In some examples,the shaft segment comprises a second shaft EEPROM. The second shaftEEPROM comprises a plurality of algorithms, routines, parameters, and/orother data corresponding to one or more shaft assemblies 150200 and/orend effectors 150300 that may be interfaced with the powered surgicalinstrument 150010.

The position encoder segment (Segment 6) comprises one or more magneticangle rotary position encoders. The one or more magnetic angle rotaryposition encoders are configured to identify the rotational position ofthe motor 150714, an interchangeable shaft assembly, and/or an endeffector 150300 of a surgical instrument. In some examples, the magneticangle rotary position encoders may be coupled to the safety controllerand/or the main controller 150717.

The motor circuit segment (Segment 7) comprises a motor 150714configured to control movements of a powered surgical instrument. Themotor 150714 is coupled to the main microcontroller processor 150717 byan H-bridge driver comprising one or more H-bridge field-effecttransistors (FETs) and a motor controller. The H-bridge driver is alsocoupled to the safety controller. A motor current sensor is coupled inseries with the motor to measure the current draw of the motor. Themotor current sensor is in signal communication with the main controller150717 and/or the safety controller. In some examples, the motor 150714is coupled to a motor electro-magnetic interference (EMI) filter.

The motor controller controls a first motor flag and a second motor flagto indicate the status and position of the motor 150714 to the maincontroller 150717. The main controller 150717 provides a pulse-widthmodulation (PWM) high signal, a PWM low signal, a direction signal, asynchronize signal, and a motor reset signal to the motor controllerthrough a buffer. The power segment is configured to provide a segmentvoltage to each of the circuit segments.

The power segment (Segment 8) comprises a battery coupled to the safetycontroller, the main controller 150717, and additional circuit segments.The battery is coupled to the segmented circuit by a battery connectorand a current sensor. The current sensor is configured to measure thetotal current draw of the segmented circuit. In some examples, one ormore voltage converters are configured to provide predetermined voltagevalues to one or more circuit segments. For example, in some examples,the segmented circuit may comprise 3.3V voltage converters and/or 5Vvoltage converters. A boost converter is configured to provide a boostvoltage up to a predetermined amount, such as, for example, up to 13V.The boost converter is configured to provide additional voltage and/orcurrent during power intensive operations and prevent brownout orlow-power conditions.

A plurality of switches are coupled to the safety controller and/or themain controller 150717. The switches may be configured to controloperations of a surgical instrument, of the segmented circuit, and/orindicate a status of the surgical instrument. A bail-out door switch andHall effect switch for bailout are configured to indicate the status ofa bail-out door. A plurality of articulation switches, such as, forexample, a left side articulation left switch, a left side articulationright switch, a left side articulation center switch, a right sidearticulation left switch, a right side articulation right switch, and aright side articulation center switch are configured to controlarticulation of an interchangeable shaft assembly and/or an endeffector. A left side reverse switch and a right side reverse switch arecoupled to the main controller 150717. The left side switches comprisingthe left side articulation left switch, the left side articulation rightswitch, the left side articulation center switch, and the left sidereverse switch are coupled to the main controller 150717 by a left flexconnector. The right side switches comprising the right sidearticulation left switch, the right side articulation right switch, theright side articulation center switch, and the right side reverse switchare coupled to the main controller 150717 by a right flex connector. Afiring switch, a clamp release switch, and a shaft engaged switch arecoupled to the main controller 150717.

Any suitable mechanical, electromechanical, or solid state switches maybe employed to implement the plurality of switches, in any combination.For example, the switches may be limit switches operated by the motionof components associated with a surgical instrument or the presence ofan object. Such switches may be employed to control various functionsassociated with the surgical instrument. A limit switch is anelectromechanical device that consists of an actuator mechanicallylinked to a set of contacts. When an object comes into contact with theactuator, the device operates the contacts to make or break anelectrical connection. Limit switches are used in a variety ofapplications and environments because of their ruggedness, ease ofinstallation, and reliability of operation. They can determine thepresence or absence, passing, positioning, and end of travel of anobject. In other implementations, the switches may be solid stateswitches that operate under the influence of a magnetic field such asHall-effect devices, magneto-resistive (MR) devices, giantmagneto-resistive (GMR) devices, magnetometers, among others. In otherimplementations, the switches may be solid state switches that operateunder the influence of light, such as optical sensors, infrared sensors,ultraviolet sensors, among others. Still, the switches may be solidstate devices such as transistors (e.g., FET, Junction-PET, metal-oxidesemiconductor-PET (MOSFET), bipolar, and the like). Other switches mayinclude wireless switches, ultra-sonic switches, accelerometers,inertial sensors, among others.

FIG. 21 is another block diagram of the control circuit 150700 of asurgical instrument illustrating interfaces between the handle assembly150702 and the power assembly 150706 and between the handle assembly150702 and the interchangeable shaft assembly 150704, in accordance withat least one aspect of this disclosure. The handle assembly 150702 maycomprise a main controller 150717, a shaft assembly connector 150726 anda power assembly connector 150730. The power assembly 150706 may includea power assembly connector 150732, a power management circuit 150734that may comprise the power management controller 150716, a powermodulator 150738, and a current sense circuit 150736. The shaft assemblyconnectors 150730, 150732 form an interface 150727. The power managementcircuit 150734 can be configured to modulate power output of the battery150707 based on the power requirements of the interchangeable shaftassembly 150704 while the interchangeable shaft assembly 150704 and thepower assembly 150706 are coupled to the handle assembly 150702. Thepower management controller 150716 can be programmed to control thepower modulator 150738 of the power output of the power assembly 150706and the current sense circuit 150736 can be employed to monitor poweroutput of the power assembly 150706 to provide feedback to the powermanagement controller 150716 about the power output of the battery150707 so that the power management controller 150716 may adjust thepower output of the power assembly 150706 to maintain a desired output.The shaft assembly 150704 comprises a shaft processor 150720 coupled toa non-volatile memory 150721 and shaft assembly connector 150728 toelectrically couple the shaft assembly 150704 to the handle assembly150702. The shaft assembly connectors 150726, 150728 form interface150725. The main controller 150717, the shaft processor 150720, and/orthe power management controller 150716 can be configured to implementone or more of the processes described herein.

The surgical instrument may comprise an output device 150742 to asensory feedback to a user. Such devices may comprise visual feedbackdevices (e.g., an LCD display screen. LED indicators), audio feedbackdevices (e.g., a speaker, a buzzer), or tactile feedback devices (e.g.,haptic actuators). In certain circumstances, the output device 150742may comprise a display 150743 that may be included in the handleassembly 150702. The shaft assembly controller 150722 and/or the powermanagement controller 150716 can provide feedback to a user of thesurgical instrument 150010 through the output device 150742. Theinterface 150727 can be configured to connect the shaft assemblycontroller 150722 and/or the power management controller 150716 to theoutput device 150742. The output device 150742 can be integrated withthe power assembly 150706. Communication between the output device150742 and the shaft assembly controller 150722 may be accomplishedthrough the interface 150725 while the interchangeable shaft assembly150704 is coupled to the handle assembly 150702. Having described acontrol circuit for controlling the operation of a surgical instrument,the disclosure now turns to various configurations of a surgicalinstrument and the control circuit 150700.

Referring to FIG. 22, a surgical stapler 151000 may include a handlecomponent 151002, a shaft component 151004, and an end-effectorcomponent 151006. The surgical stapler 151000 is similarly constructedand equipped as the motor-driven surgical cutting and fasteninginstrument 150010 described in connection with FIG. 16. Accordingly, forconciseness and clarity the details of operation and construction willnot be repeated here. The end-effector 151006 may be used to compress,cut, or staple tissue. Referring now to FIG. 23, an end-effector 151030may be positioned by a physician to surround tissue 151032 prior tocompression, cutting, or stapling. As shown in FIG. 23, no compressionmay be applied to the tissue while preparing to use the end-effector.Referring now to FIG. 24, by engaging the handle (e.g., handle 151002)of the surgical stapler, the physician may use the end-effector 151030to compress the tissue 151032. In one aspect, the tissue 151032 may becompressed to its maximum threshold, as shown in FIG. 24. Referring toFIG. 25, various forces may be applied to the tissue 151032 by theend-effector 151030. For example, vertical forces F1 and F2 may beapplied by the anvil 151034 and the channel frame 151036 of theend-effector 151030 as tissue 151032 is compressed between the two.Referring now to FIG. 26, various diagonal and/or lateral forces alsomay be applied to the tissue 151032 when compressed by the end-effector151030. For example, force F3 may be applied. For the purposes ofoperating a medical device such as surgical stapler 151000, it may bedesirable to sense or calculate the various forms of compression beingapplied to the tissue by the end-effector. For example, knowledge ofvertical or lateral compression may allow the end-effector to moreprecisely or accurately apply a staple operation or may inform theoperator of the surgical stapler such that the surgical stapler can beused more properly or safely.

The compression through tissue 151032 may be determined from animpedance of tissue 151032. At various levels of compression, theimpedance Z of tissue 151032 may increase or decrease. By applying avoltage V and a current I to the tissue 151032, the impedance Z of thetissue 151032 may be determined at various levels of compression. Forexample, impedance Z may be calculated by dividing the applied voltage Vby the current I.

Referring now to FIG. 27, in one aspect, an RF electrode 151038 may bepositioned on the end-effector 151030 (e.g., on a staple cartridge,knife, or channel frame of the end-effector 151030). Further, anelectrical contact 151040 may be positioned on the anvil 151034 of theend-effector 151030. In one aspect, the electrical contact may bepositioned on the channel frame of the end-effector. As the tissue151032 is compressed between the anvil 151034 and, for example, thechannel frame 151036 of the end-effector 151030, an impedance 7 of thetissue 151032 changes. The vertical tissue compression 151042 caused bythe end-effector 151030 may be measured as a function of the impedance Zof the tissue 151032.

Referring now to FIG. 28, in one aspect, an electrical contact 151044may be positioned on an opposite end of the anvil 151034 of theend-effector 151030 as the RF electrode 151038 is positioned. As thetissue 151032 is compressed between the anvil 151034 and, for example,the channel frame 151036 of the end-effector 151030, an impedance Z ofthe tissue 151032 changes. The lateral tissue compression 151046 causedby the end-effector 151030 may be measured as a function of theimpedance 7 of the tissue 151032.

Referring now to FIG. 29, in one aspect, electrical contact 151050 maybe positioned on the anvil 151034 and electrical contact 151052 may bepositioned on an opposite end of the end-effector 151030 at channelframe 151036. RF electrode 151048 may be positioned laterally to thecentral to the end-effector 151030. As the tissue 151032 is compressedbetween the anvil 151034 and, for example, the channel frame 151036 ofthe end-effector 151030, an impedance Z of the tissue 151032 changes.The lateral compression or angular compression 151054 and 151056 oneither side of the RF electrode 151048 may be caused by the end-effector151030 and may be measured as a function of different impedances Z ofthe tissue 151032, based on the relative positioning of the RF electrode151048 and electrical contacts 151050 and 151052.

Referring now to FIG. 30, a frequency generator 151222 may receive poweror current from a power source 151221 and may supply one or more RFsignals to one or more RF electrodes 151224. As discussed above, the oneor more RF electrodes may be positioned at various locations orcomponents on an end-effector or surgical stapler, such as a staplecartridge or channel frame. One or more electrical contacts, such aselectrical contacts 151226 or 151228 may be positioned on a channelframe or an anvil of an end-effector. Further, one or more filters, suchas filters 151230 or 151232 may be communicatively coupled to theelectrical contacts 151226 or 151228. The filters 151230 and 151232 mayfilter one or more RF signals supplied by the frequency generator 151222before joining a single return path 151234. A voltage V and a current Iassociated with the one or more RF signals may be used to calculate animpedance Z associated with a tissue that may be compressed and/orcommunicatively coupled between the one or more RF electrodes 151224 andthe electrical contacts 151226 or 151228.

Referring still to FIG. 30, various components of the tissue compressionsensor system described herein may be located in a handle 151236 of asurgical stapler. For example, as shown in circuit diagram 151220 a,frequency generator 151222 may be located in the handle 151236 andreceives power from power source 151221. Also, current I1 and current I2may be measured on a return path corresponding to electrical contacts151228 and 151226. Using a voltage V applied between the supply andreturn paths, impedances Z1 and Z2 may be calculated. Z1 may correspondto an impedance of a tissue compressed and/or communicatively coupledbetween one or more of RF electrodes 151224 and electrical contact151228. Further, Z2 may correspond to an impedance of a tissuecompressed and/or communicatively coupled between one or more of RFelectrodes 151224 and electrical contact 151226. Applying the formulasZ1=V/I1 and Z2=V/I2, impedances Z1 and Z2 corresponding to differentcompression levels of a tissue compressed by an end-effector may becalculated.

Referring now to FIG. 31, one or more aspects of the present disclosureare described in circuit diagram 151250. In an implementation, a powersource at a handle 151252 of a surgical stapler may provide power to afrequency generator 151254. The frequency generator 151254 may generateone or more RF signals. The one or more RF signals may be multiplexed oroverlaid at a multiplexer 151256, which may be in a shaft 151258 of thesurgical stapler. In this way, two or more RF signals may be overlaid(or, e.g., nested or modulated together) and transmitted to theend-effector. The one or more RF signals may energize one or more RFelectrodes 151260 at an end-effector 151262 (e.g., positioned in astaple cartridge) of the surgical stapler. A tissue (not shown) may becompressed and/or communicatively coupled between the one or more of RFelectrodes 151260 and one or more electrical contacts. For example, thetissue may be compressed and/or communicatively coupled between the oneor more RF electrodes 151260 and the electrical contact 151264positioned in a channel frame of the end-effector 151262 or theelectrical contact 151266 positioned in an anvil of the end-effector151262. A filter 151268 may be communicatively coupled to the electricalcontact 151264 and a filter 151270 may be communicatively coupled to theelectrical contact 151266.

A voltage V and a current I associated with the one or more RF signalsmay be used to calculate an impedance Z associated with a tissue thatmay be compressed between the staple cartridge (and communicativelycoupled to one or more RF electrodes 151260) and the channel frame oranvil (and communicatively coupled to one or more of electrical contacts151264 or 151266).

In one aspect, various components of the tissue compression sensorsystem described herein may be located in a shaft 151258 of the surgicalstapler. For example, as shown in circuit diagram 151250 (and inaddition to the frequency generator 151254), an impedance calculator151272, a controller 151274, a non-volatile memory 151276, and acommunication channel 151278 may be located in the shaft 151258. In oneexample, the frequency generator 151254, impedance calculator 151272,controller 151274, non-volatile memory 151276, and communication channel151278 may be positioned on a circuit board in the shaft 151258.

The two or more RF signals may be returned on a common path via theelectrical contacts. Further, the two or more RF signals may be filteredprior to the joining of the RF signals on the common path todifferentiate separate tissue impedances represented by the two or moreRF signals. Current I1 and current I2 may be measured on a return pathcorresponding to electrical contacts 151264 and 151266. Using a voltageV applied between the supply and return paths, impedances Z1 and Z2 maybe calculated. Z1 may correspond to an impedance of a tissue compressedand/or communicatively coupled between one or more of RF electrodes151260 and electrical contact 151264. Further, Z2 may correspond to animpedance of the tissue compressed and/or communicatively coupledbetween one or more of RF electrodes 151260 and electrical contact151266. Applying the formulas Z1=V/I1 and Z2=V/I2, impedances Z1 and Z2corresponding to different compressions of a tissue compressed by anend-effector 151262 may be calculated. In example, the impedances Z1 andZ2 may be calculated by the impedance calculator 151272. The impedancesZ1 and Z2 may be used to calculate various compression levels of thetissue.

FIG. 32 is a diagram of a position sensor 153200 for an absolutepositioning system 153100′ comprising a magnetic rotary absolutepositioning system, in accordance with at least one aspect of thisdisclosure. The absolute positioning system 153100′ is similar in manyrespects to the absolute positioning system 153100. The position sensor153200 may be implemented as an AS5055EQFT single chip magnetic rotaryposition sensor available from Austria Microsystems, AG. The positionsensor 153200 is interfaced with the controller 153110 to provide theabsolute positioning system 153100′. The position sensor 153200 is a lowvoltage and low-power component and includes four Hall-effect elements153228A, 153228B, 153228C, 153228D in an area 153230 of the positionsensor 153200 that is located above a magnet positioned on a rotatingelement associated with a displacement member such as, for example, aknife drive gear and/or a closure drive gear such that the displacementof a firing member and/or a closure member can be precisely tracked. Ahigh-resolution ADC 153232 and a smart power management controller153238 are also provided on the chip. A CORDIC processor 153236 (forCoordinate Rotation Digital Computer), also known as the digit-by-digitmethod and Voider's algorithm, is provided to implement a simple andefficient algorithm to calculate hyperbolic and trigonometric functionsthat require only addition, subtraction, bitshift, and table lookupoperations. The angle position, alarm bits, and magnetic fieldinformation are transmitted over a standard serial communicationinterface such as an SPI interface 153234 to the controller 153110. Theposition sensor 153200 provides 12 or 14 bits of resolution. Theposition sensor 153200 may be an AS5055 chip provided in a small QFN16-pin 4×4×0.85 mm package.

The Hall-effect elements 153228A, 153228B, 153228C, 153228D are locateddirectly above the rotating magnet. The Hall-effect is a well-knowneffect and for expediency will not be described in detail herein,however, generally, the Hall-effect produces a voltage difference (theHall voltage) across an electrical conductor transverse to an electriccurrent mi the conductor and a magnetic field perpendicular to thecurrent. A Hall coefficient is defined as the ratio of the inducedelectric field to the product of the current density and the appliedmagnetic field. It is a characteristic of the material from which theconductor is made, since its value depends on the type, number, andproperties of the charge carriers that constitute the current. In theAS5055 position sensor 153200, the Hall-effect elements 153228A,153228B, 153228C, 153228D are capable producing a voltage signal that isindicative of the absolute position of the magnet in terms of the angleover a single revolution of the magnet. This value of the angle, whichis unique position signal, is calculated by the CORDIC processor 153236is stored onboard the AS5055 position sensor 153200 in a register ormemory. The value of the angle that is indicative of the position of themagnet over one revolution is provided to the controller 153110 in avariety of techniques. e.g., upon power up or upon request by thecontroller 153110.

The AS5055 position sensor 153200 requires only a few externalcomponents to operate when connected to the controller 153110. Six wiresare needed for a simple application using a single power supply: twowires for power and four wires 153240 for the SPI interface 153234 withthe controller 153110. A seventh connection can be added in order tosend an interrupt to the controller 153110 to inform that a new validangle can be read. Upon power-up, the AS5055 position sensor 153200performs a full power-up sequence including one angle measurement. Thecompletion of this cycle is indicated as an INT output 153242, and theangle value is stored in an internal register. Once this output is set,the AS5055 position sensor 153200 suspends to sleep mode. The controller153110 can respond to the INT request at the INT output 153242 byreading the angle value from the AS5055 position sensor 153200 over theSPI interface 153234. Once the angle value is read by the controller153110, the INT output 153242 is cleared again. Sending a “read angle”command by the SPI interface 153234 by the controller 153110 to theposition sensor 153200 also automatically powers up the chip and startsanother angle measurement. As soon as the controller 153110 hascompleted reading of the angle value, the INT output 153242 is clearedand a new result is stored in the angle register. The completion of theangle measurement is again indicated by setting the INT output 153242and a corresponding flag in the status register.

Due to the measurement principle of the AS5055 position sensor 153200,only a single angle measurement is performed in very short time (˜600μs) after each power-up sequence. As soon as the measurement of oneangle is completed, the AS5055 position sensor 153200 suspends topower-down state. An on-chip filtering of the angle value by digitalaveraging is not implemented, as this would require more than one anglemeasurement and, consequently, a longer power-up time that is notdesired in low-power applications. The angle jitter can be reduced byaveraging of several angle samples in the controller 153110. Forexample, an averaging of four samples reduces the jitter by 6 dB (50%).

FIG. 33 is a section view of an end effector 153502 showing an I-beam153514 firing stroke relative to tissue 153526 grasped within the endeffector 153502, in accordance with at least one aspect of thisdisclosure. The end effector 153502 is configured to operate with any ofthe surgical instruments or systems in accordance with the presentdisclosure. The end effector 153502 comprises an anvil 153516 and anelongated channel 153503 with a staple cartridge 153518 positioned inthe elongated channel 153503. A firing bar 153520 is translatabledistally and proximally along a longitudinal axis 153515 of the endeffector 153502. When the end effector 153502 is not articulated, theend effector 153502 is in line with the shaft of the instrument. AnI-beam 153514 comprising a cutting edge 153509 is illustrated at adistal portion of the firing bar 153520. A wedge sled 153513 ispositioned in the staple cartridge 153518. As the I-beam 153514translates distally, the cutting edge 153509 contacts and may cut tissue153526 positioned between the anvil 153516 and the staple cartridge153518. Also, the I-beam 153514 contacts the wedge sled 153513 andpushes it distally, causing the wedge sled 153513 to contact stapledrivers 153511. The staple drivers 153511 may be driven up into staples153505, causing the staples 153505 to advance through tissue and intopockets 153507 defined in the anvil 153516, which shape the staples153505.

An example I-beam 153514 firing stroke is illustrated by a chart 153529aligned with the end effector 153502. Example tissue 153526 is alsoshown aligned with the end effector 153502. The firing member stroke maycomprise a stroke begin position 153527 and a stroke end position153528. During an I-beam 153514 firing stroke, the I-beam 153514 may beadvanced distally from the stroke begin position 153527 to the strokeend position 153528. The I-beam 153514 is shown at one example locationof a stroke begin position 153527. The I-beam 153514 firing memberstroke chart 153529 illustrates five firing member stroke regions153517, 153519, 153521, 153523, 153525. In a first firing stroke region153517, the I-beam 153514 may begin to advance distally. In the firstfiring stroke region 153517, the I-beam 153514 may contact the wedgesled 153513 and begin to move it distally. While in the first region,however, the cutting edge 153509 may not contact tissue and the wedgesled 153513 may not contact a staple driver 153511. After staticfriction is overcome, the force to drive the I-beam 153514 in the firstregion 153517 may be substantially constant.

In the second firing member stroke region 153519, the cutting edge153509 may begin to contact and cut tissue 153526. Also, the wedge sled153513 may begin to contact staple drivers 153511 to drive staples153505. Force to drive the I-beam 153514 may begin to ramp up. As shown,tissue encountered initially may be compressed and/or thinner because ofthe way that the anvil 153516 pivots relative to the staple cartridge153518. In the third firing member stroke region 153521, the cuttingedge 153509 may continuously contact and cut tissue 153526 and the wedgesled 153513 may repeatedly contact staple drivers 153511. Force to drivethe I-beam 153514 may plateau in the third region 153521.

By the fourth firing stroke region 153523, force to drive the I-beam153514 may begin to decline. For example, tissue in the portion of theend effector 153502 corresponding to the fourth firing region 153523 maybe less compressed than tissue closer to the pivot point of the anvil153516, requiring less force to cut. Also, the cutting edge 153509 andwedge sled 153513 may reach the end of the tissue 153526 while in thefourth region 153523. When the I-beam 153514 reaches the fifth region153525, the tissue 153526 may be completely severed. The wedge sled153513 may contact one or more staple drivers 153511 at or near the endof the tissue. Force to advance the I-beam 153514 through the fifthregion 153525 may be reduced and, in some examples, may be similar tothe force to drive the I-beam 153514 in the first region 153517. At theconclusion of the firing member stroke, the I-beam 153514 may reach thestroke end position 153528.

As discussed above, the electric motor 153120 positioned within a mastercontroller of the surgical instrument and can be utilized to advanceand/or retract the firing system of the shaft assembly, including theI-beam 153514, relative to the end effector 153502 of the shaft assemblyin order to staple and/or incise tissue captured within the end effector153502. The I-beam 153514 may be advanced or retracted at a desiredspeed, or within a range of desired speeds. The controller 153110 may beconfigured to control the speed of the I-beam 153514. The controller153110 may be configured to predict the speed of the I-beam 153514 basedon various parameters of the power supplied to the electric motor153120, such as voltage and/or current, for example, and/or otheroperating parameters of the electric motor 153120 or externalinfluences. The controller 153110 may be configured to predict thecurrent speed of the I-beam 153514 based on the previous values of thecurrent and/or voltage supplied to the electric motor 153120, and/orprevious states of the system like velocity, acceleration, and/orposition. The controller 153110 may be configured to sense the speed ofthe I-beam 153514 utilizing the absolute positioning sensor systemdescribed herein. The controller can be configured to compare thepredicted speed of the I-beam 153514 and the sensed speed of the I-beam153514 to determine whether the power to the electric motor 153120should be increased in order to increase the speed of the I-beam 153514and/or decreased in order to decrease the speed of the I-beam 153514.

Force acting on the I-beam 153514 may be determined using varioustechniques. The I-beam 153514 force may be determined by measuring themotor 153120 current, where the motor 153120 current is based on theload experienced by the I-beam 153514 as it advances distally. TheI-beam 153514 force may be determined by positioning a strain gauge onthe drive member, the firing member, I-beam 153514, the firing bar,and/or on a proximal end of the cutting edge 153509. The I-beam 153514force may be determined by monitoring the actual position of the I-beam153514 moving at an expected velocity based on the current set velocityof the motor 153120 after a predetermined elapsed period T1 andcomparing the actual position of the I-beam 153514 relative to theexpected position of the I-beam 153514 based on the current set velocityof the motor 153120 at the end of the period T1. Thus, if the actualposition of the I-beam 153514 is less than the expected position of theI-beam 153514, the force on the I-beam 153514 is greater than a nominalforce. Conversely, if the actual position of the I-beam 153514 isgreater than the expected position of the I-beam 153514, the force onthe I-beam 153514 is less than the nominal force. The difference betweenthe actual and expected positions of the I-beam 153514 is proportionalto the deviation of the force on the I-beam 153514 from the nominalforce.

Various aspects of the present disclosure are directed to improvedsafety systems capable of adapting, controlling, and/or tuning internaldrive operations of a surgical instrument in response to tissueparameters detected via one or more than one sensor of the surgicalinstrument. In accordance with at least one aspect, a force detected,via one or more than one sensor, at the laws of an end effector may beof a magnitude that prohibits one or more than one subsequent/furtherfunctionality of the end effector from being performed. According toanother aspect, a metallic object may be detected, via one or more thanone sensor, as within the laws of the end effector that prohibits one ormore than one subsequent/further functionality of the end effector frombeing performed. FIG. 34 illustrates a surgical system 23000 comprisinga surgical instrument 23002, a surgical hub 23004, and a user interface23006. In such an aspect, the surgical instrument 23002 may comprise oneor more than one sensor 23008 and parameters detected by the one or morethan one sensor 23008 of the surgical instrument 23002 may betransmitted/communicated (e.g., wirelessly) to a control circuit 23010of the surgical hub 23004. Further, in such an aspect, the surgical hub23004 may be configured to determine whether a surgical function (e.g.,dissect, clamp, coagulate, staple, cut, rotate, articulate, etc.)associated with a component (e.g., end effector, shaft, etc.) of thesurgical instrument 23002 may be performed safely based on theparameters detected by the one or more than one sensor 23008 of thesurgical instrument 23002. Notably, in such an aspect, the surgical hub23004 may be configured to transmit/communicate a result(s) (i.e., awarning associated with the surgical function, a reason the surgicalfunction is prevented, etc.) associated with that determination to theuser interface 23006. Further, according to various aspects, varioususer interfaces disclosed herein may comprise a selectable userinterface feature (e.g., override element 23012) to proceed with thesurgical function despite any warnings and/or reasons supportingprevention. Notably, in such aspects, such a user interface feature(e.g., override element 23012) may not be displayed (e.g., performingthe surgical function may endanger the patient).

Referring to FIG. 35, according to various aspects of the presentdisclosure, a surgical system 23100 may comprise a control circuit(23112, 23122, 23132 and/or 23142, e.g., in phantom to show optionallocation(s)), a user interface (23118, 23128, 23138, 23148 and/or 23158,e.g., in phantom to show optional locations), and a surgical instrument23102 including, for example, a handle assembly 23110, a shaft assembly23120, and an end effector assembly 23130. In such aspects, the controlcircuit may be integrated into one or more than one component (e.g., thehandle assembly 23110, the shaft assembly 23120, and/or the end effectorassembly 23130, etc.) of the surgical instrument 23102 (e.g., 23112,23122, and/or 23132) and/or integrated into a surgical hub 23140 (e.g.,23142) paired (e.g., wirelessly) with the surgical instrument 23102.Notably, according to various aspects, the surgical instrument 23102and/or the surgical hub 23140 may be a situationally aware surgicalinstrument and/or a situationally aware surgical hub. Situationalawareness refers to the ability of a surgical system, e.g., 23100, todetermine or infer information related to a surgical procedure from datareceived from databases (e.g., historical data associated with asurgical procedure, e.g., 23149 and/or 23150) and/or surgicalinstruments (e.g., sensor data during a surgical procedure). Forexample, the determined or inferred information can include the type ofprocedure being undertaken, the type of tissue being operated on, thebody cavity that is the subject of the procedure, etc. Based on suchcontextual information related to the surgical procedure, the surgicalsystem can, for example, control a paired surgical instrument 23102 or acomponent thereof (e.g., 23110, 23120, and/or 23130) and/or providecontextualized information or suggestions to a surgeon throughout thecourse of the surgical procedure (e.g., via user interface 23118, 23128,23138, 23148 and/or 23158). Additional details regarding situationalawareness can be found, for example, above under the heading“Situational Awareness.”

Also in FIG. 35, according to one aspect, a situationally aware surgicalhub 23140 is paired (e.g., wirelessly) with a surgical instrument 23102being utilized to perform a surgical procedure. In such an aspect, thesurgical instrument 23102 may comprise an end effector assembly 23130,including a first jaw, a second jaw pivotably coupled to the first jaw,and a sensor 23134 configured to detect a parameter associated with afunction (e.g., dissect, clamp, coagulate, cut, staple, etc.) of the endeffector assembly 23130 and to transmit the detected parameter to acontrol circuit 23142 of the surgical hub 23140.

Further, in such an aspect, the surgical instrument 23102 may furthercomprise a shaft assembly 23120 including a sensor 23124 configured todetect a parameter associated with a function (e.g., rotation,articulation, etc.) of the shaft assembly 23120 and to transmit thedetected parameter to the control circuit 23142 of the surgical hub23140. Notably, it should be appreciated that a sensor, as referencedherein and in other disclosed aspects, may comprise a plurality ofsensors configured to detect a plurality of parameters associated with aplurality of end effector assembly and/or shaft assembly functions. Assuch, further, in such an aspect, the surgical hub control circuit 23142may be configured to receive detected parameters (e.g., sensor data)from such sensors 23134 and/or 23124 throughout the course of thesurgical procedure.

A detected parameter can be received each time an associated endeffector assembly 23130 function (e.g., dissection, clamping,coagulation, cutting, stapling, etc.) and/or an associated shaftassembly 23120 function (e.g., rotating, articulating, etc.) isperformed. The surgical hub control circuit 23142 may be furtherconfigured to receive data from an internal database (e.g., a surgicalhub database 23149) and/or an external database (e.g., from a clouddatabase 23150) throughout the course of the surgical procedure.According to various aspects, the data received from the internal and/orexternal databases may comprise procedural data (e.g., steps to performthe surgical procedure) and/or historical data (e.g., data indicatingexpected parameters based on historical data associated with thesurgical procedure).

In various aspects, the procedural data may comprise current/recognizedstandard-of-care procedures for the surgical procedure and thehistorical data may comprise preferred/ideal parameters and/orpreferred/ideal parameter ranges based on historical data associatedwith the surgical procedure (e.g., system-defined constraints). Based onthe received data (e.g., sensor data, internal and/or external data,etc.), the surgical hub control circuit 23142 may be configured tocontinually derive inferences (e.g., contextual information) about theongoing surgical procedure. Namely, the situationally aware surgical hubmay be configured to, for example, record data pertaining to thesurgical procedure for generating reports, verify the steps being takenby the surgeon to perform the surgical procedure, provide data orprompts (e.g., via a user interface associated with the surgical huband/or the surgical instrument, e.g., 23148, 23158, 23118, 23128, and/or23138) that may be pertinent for a particular procedural step, control asurgical instrument function, etc. According to various aspects, thesituationally aware surgical hub 23140 may (e.g., after an initialsurgical function of the end effector assembly 23130 or the shaftassembly 23120 is performed) infer a next surgical function to beperformed based on procedural data received from an internal database23149 and/or an external database 23150.

Further, in such an aspect, the situationally aware surgical hub 23140may evaluate detected parameters (e.g., received from sensors 23134and/or 23124 in response to the initial surgical function) based onhistorical data received from the internal database 23149 and/or theexternal database 23150 (e.g., preferred/ideal parameters). Here, if thedetected parameters do not exceed the preferred/ideal parameters and/orare within respective preferred/ideal parameter ranges, thesituationally aware surgical hub 23140 may permit the next surgicalfunction to be performed and/or not prevent/control the next surgicalfunction from being performed. Alternatively, if the detected parametersdo exceed the preferred/ideal parameters and/or are not withinrespective preferred/ideal parameter ranges, the situationally awaresurgical hub 23140 may proactively prevent the next surgical functionfrom being performed.

According to another aspect of the present disclosure, the situationallyaware surgical hub 23140 may receive a communication (e.g., from acomponent, e.g., 23130 and/or 23120, of the surgical instrument 23102)that a particular surgical function is beingattempted/requested/actuated. In such an aspect, the situationally awaresurgical hub 23140 may compare that particular surgical function to aninferred next surgical function to ensure that current/recognizedstandard-of-care procedures are being adhered to. If so, thesituationally aware surgical hub 23140 may then evaluate detectedparameters (e.g., as described) before permitting that particularsurgical function to proceed (as described). If not, the situationallyaware surgical hub 23140 may prevent that particular surgical functionfrom being performed or prevent that particular surgical function frombeing performed until an override is received (e.g., via a userinterface 23158, 23148, 23138, 23128 and/or 23118, see, e.g., FIG. 34,selectable user interface element 23012). In such an aspect, if theoverride is received, the situationally aware surgical hub 23140 maythen evaluate detected parameters before permitting that particularsurgical function to proceed (as described).

Referring again to FIG. 35, according to another aspect, a situationallyaware surgical instrument 23102 may be utilized to perform a surgicalprocedure. In such an aspect, the surgical instrument 23102 may comprisea handle assembly 23110, a shaft assembly 23120, and an end effectorassembly 23130. The end effector assembly 23130 may include a first jaw,a second jaw pivotably coupled to the first jaw, and a sensor 23134configured to detect a parameter associated with a function (e.g.,dissect, clamp, coagulate, cut, staple, etc.) of the end effectorassembly 23130 and to transmit the detected parameter to a controlcircuit (23112, 23122, 23132 and/or 23142, e.g., in phantom to showoptional location(s)).

For example, in such an aspect, the detected parameter may betransmitted to a control circuit 23132 of the end effector assembly23130. Here, the end effector assembly control circuit 23132 may beconfigured to receive detected parameters (e.g., sensor data) from thesensor 23134 throughout the course of the surgical procedure. A detectedparameter can be received each time an associated end effector assembly23130 function (e.g., dissection, clamping, coagulation, cutting,stapling, etc.) is performed.

The end effector assembly 23130 may be further configured to receivedata from an internal database (e.g., end effector memory 23136) and/oran external database (e.g., from a cloud database 23150 via a surgicalhub 23140, from a surgical hub database 23149, etc.) throughout thecourse of the surgical procedure. According to various aspects, the datareceived from the internal and/or external databases may comprise staplecartridge data (e.g., sizes and/or types of staples associated with astaple cartridge positioned in the end effector assembly) and/orhistorical data (e.g., data indicating expected tissues and/or types oftissues to be stapled with those sizes and/or types of staples based onhistorical data). In various aspects, the received data may comprisepreferred/ideal parameters and/or preferred/ideal parameter rangesassociated with those sizes and/or types of staples or those expectedtissues and/or tissue types, based on historical data (e.g.,system-defined constraints). Based on the received data (e.g., sensordata, internal and/or external data, etc.), the end effector controlcircuit 23132 may be configured to continually derive inferences (e.g.,contextual information) about the ongoing surgical procedure. Notably,according to an alternative aspect, the sensor 23134 of the end effectorassembly 23130 may transmit the detected parameter to a control circuit(e.g., 23112 and/or 23122) associated with another surgical instrument23102 component, for example, the handle assembly 23110 and/or the shaftassembly 23120. In such an aspect, that other surgical instrumentcomponent control circuit (e.g., 23112 and/or 23122) may be similarlyconfigured to perform the various aspects of the end effector controlcircuit 23132 as described above. Furthermore, according to variousaspects, the shaft assembly 23120 of the surgical instrument 23102 mayinclude a sensor 23124 configured to detect a parameter associated witha function (e.g., rotation, articulation, etc.) of the shaft assembly23120 and to transmit the detected parameter to a control circuit (e.g.,23112) similarly configured to perform the various aspects of the endeffector control circuit 23132 as described above. In end, thesituationally aware surgical instrument 23102 may be configured to, forexample, alert its user of a discrepancy (e.g., via a user interface23138 of the end effector assembly 23130, via a user interface (e.g.,23128 and/or 23118) of another surgical instrument 23102 component, forexample, the shaft assembly 23120 and/or the handle assembly 23110,and/or via a user interface 23148 and/or 23158 associated with asurgical hub 23140 coupled to the surgical instrument 23102). Forexample, the discrepancy may include that a detected parameter exceeds apreferred/ideal parameter and/or a preferred/ideal parameter rangeassociated with those sizes and/or types of staples or those expectedtissues and/or tissue types. As a further example, the situationallyaware surgical instrument 23102 may be configured to control a surgicalinstrument 23102 function based on the discrepancy. In accordance withat least one aspect, the situationally aware surgical instrument 23102may prevent a surgical function based on a discrepancy.

As highlighted herein, various aspects of the present disclosure pertainto a surgical instrument performing a function (e.g., clamping),detecting a parameter associated with that function, using situationalawareness aspects to assess, via a control circuit, whether thatdetected parameter is below or exceeds a predefined parameter (e.g.,considered ideal/preferred) or is below or exceeds a predefined range(e.g., considered normal) for that parameter, and performing an action(i.e., stop a function(s), alert the user, inform the user of possiblecauses, etc.) in response to the detected parameter being outside thepredefined parameter and/or predefined parameter/range. For example.FIG. 36 illustrates an algorithm 23200 to implement such aspects whereina control circuit receives a detected parameter(s) associated with asurgical function performed by a surgical instrument 23202 and retrievessituational awareness data from an internal and/or external database23204. The control circuit then evaluates the detected parameter(s) inview of the situational awareness data 23206 and performs an actionbased on the evaluation 23208.

According to various aspects of the present disclosure, a force detected(e.g., via one or more than one sensor) at the jaws of an end effectorassembly may be of a magnitude that prohibits one or more than onesubsequent/further functionality of the end effector assembly from beingperformed. In such an aspect, the sensor may be a strain gauge coupledto the end effector wherein the strain gauge is configured to measurethe magnitude/amplitude of strain on a jaw(s) of the end effector, whichis indicative of closure forces being applied to the jaw(s). Further, insuch an aspect, sensor may be a load sensor configured to measure aclosure force applied to the jaws by a closure drive system. Yetfurther, in such an aspect, sensor may be a current sensor configured tomeasure a current drawn by the motor, which correlates to a closureforce applied to the jaws.

FIG. 37 illustrates a logic flow diagram of a process 21200 forcontrolling a surgical instrument according to the physiological type ofthe clamped tissue, in accordance with at least one aspect of thepresent disclosure. The illustrated process can be executed by, forexample, the control circuit 21002 of the surgical instrument 21000.Accordingly, the control circuit 21002 executing the illustrated process21200 receives 21202 tissue contact data and/or signals from thesensor(s) 21004. The received 21202 tissue contact data and/or signalsindicate whether tissue is contacting at least one of the sensors 21004.Accordingly, the control circuit 21002 can determine 21204 the initialpoint of contact between the end effector 21008 and the tissue beingclamped In one aspect, the control circuit 21002 determines 21204 whenthe initial tissue contact occurs by detecting when at least one of thesensors 21004 disposed on each of the jaws detects tissue contactthereagainst.

Accordingly, the control circuit 21002 determines 21206 the position ofthe jaws at the initial tissue contact point. In one aspect, the controlcircuit 21002 is communicably coupled to a Hall effect sensor disposedon one of the laws of the end effector 21008 that is configured todetect the relative position of a corresponding magnetic elementdisposed on the opposing jaw. The control circuit 21002 can thusdetermine 21206 the position of the jaws according to the senseddistance or gap therebetween. In another aspect, the control circuit21002 is communicably coupled to a position sensor that is configured todetect the absolute or relative position of a closure tube that isconfigured to close the jaws as the closure tube is driven from a firstor proximal position to a second or distal position. The control circuit21002 can thus determine 21206 the position of the jaws according to thesensed position of the closure tube. In yet another aspect, the controlcircuit 21002 is communicably coupled to an angle sensor, such as aTLE5012B 360° angle sensor from Infineon Technologies, that isconfigured to detect the angle at which at least one of the jaws isoriented. The control circuit 21002 can thus determine 21206 theposition of the jaws according to the sensed angle at which the jaw(s)are oriented.

Accordingly, the control circuit 21002 determines 21208 the degree ofcontact between the grasped tissue and the tissue-contacting surface(s)of the jaws. The degree of tissue contact can correspond to the numberor ratio of the sensors 21004 that have detected the presence (orabsence) of tissue. In one aspect, the control circuit 21002 candetermine the degree of tissue contact according to the ratio of thesensor(s) 21004 that have detected the presence of tissue to thesensor(s) 21004 that have not detected the presence of tissue.

Accordingly, the control circuit 21002 sets 21210 control parameters forthe motor 21006 according to the determined 21206 position of the jawsand the determined 21208 degree of tissue contact. The motor controlparameters can include, for example, the time to close the jaws and/orclosure threshold(s). In one aspect, the control circuit 21002 can beconfigured to perform a runtime calculation and/or access a memory(e.g., a lookup table) to retrieve the motor control parameters (e.g.,the jaw closure rate and closure threshold) associated with theparticular position of the jaws and the particular degree of tissuecontact sensed via the various sensors. In various aspects, the controlcircuit 21002 can control the motor 21006 to adjust the jaw closure timeby, for example, adjusting the rate at which the jaws are transitionedfrom the open position to the closed position, adjusting the length oftime that the jaws are paused after the initial clamping of the tissue(i.e., the tissue creep wait time), and/or adjusting the stabilizationthreshold that ends the clamping phase. In various aspects, the closurethreshold(s) can include, for example, the maximum allowable FTC the endeffector 21008 or rate of change for the FTC (i.e., IIFTC) at which thecontrol circuit 21002 stops the motor 21006 driving the closure of thejaws or takes other actions, as discussed above under the heading“Compression Rate to Determine Tissue Integrity.” The control circuit21002 can then control the motor 21206 according to the motor controlparameters set 21210 by the process 21200.

The position of the jaws and the degree of contact with the tissue atthe initial point of contact with the tissue corresponds to thethickness or geometry of the tissue being grasped, which in turncorresponds to the physiological type of the tissue. Thus, the controlcircuit 21002 can be configured to differentiate between tissue typesand then set 21210 the control parameters for the motor 21006accordingly. For example, the control circuit 21002 can be configured todetermine whether parenchyma or vessel tissue has been grasped by theend effector 21008 and then set 21210 motor control parameters that areappropriate for the detected tissue type.

In some aspects, jaw closure rate can be selected for each tissue typeto maintain the maximum FTC and/or IIFTC under a particular closurethreshold, which can likewise be selected for each tissue type. In oneaspect, the control circuit 21002 can be configured to institute amini-mum clamp rate so that the closure motion of the jaws is neverpermanently halted. In one aspect, the control circuit 21002 can beconfigured to control the maximum pause times to ensure that jaw closureprogresses at least a default rate. In one aspect, the control circuit21002 can be configured to halt the motor 21006 and/or provide feedbackto the user when closure threshold(s) are exceeded or otherwise beachedduring user of the surgical instrument 21000.

It should be noted that although the steps of the particular example ofthe process 21200 in FIG. 37 are depicted as occurring in a particularorder or sequence, such a depiction is solely for illustrative purposesand no particular sequence of the process 21200 is intended, unless aparticular sequence of particular steps is explicitly necessary from thedescription hereabove. For example, in other aspects of the process21200, the control circuit 21002 can determine 21208 the degree oftissue contact prior to determining 21206 the jaw position at theinitial contact point.

FIG. 38 is a flow diagram 22200 of an aspect of adjusting a closure ratealgorithm by the computer-implemented interactive surgical system 10,according to one aspect of the present disclosure. At step 22202, thecurrent closure algorithm is determined. This may refer to determiningthe closure control program currently executed by the control circuit500 of a surgical instrument 112. The current closure algorithm orcontrol program may include a closure threshold function (e.g., closurethreshold parameter) and applied closure force (FTC) function (e.g.,closure rate of change parameter). The flow diagram 22200 proceeds nextto step 22204, where preoperative information is received and analyzed.As discussed above, preoperative information may include initial tissuethickness based on tissue contact sensors 474, patient history includingprior diagnoses and treatments (e.g., listed on a patient informationEMR record stored in the hub or cloud), clinician history such as asurgeon's typical surgical routine, identified surgical instrument andassociated materials, and identified current surgical procedure. Thispreoperative information can be used to determine, infer, or predicttissue type or tissue characteristics at step 22206.

For example, the undeformed initial tissue thickness as measured bytissue contact sensors 474 may be used to determine an initial closurealgorithm. Preoperative information such as a patient history of lungissues might be used to determine that the current surgical procedurebeing performed is a thoracic procedure and the tissue type is a kungtissue. This preoperative information may further be used to determinean adjustment to the initial closure algorithm. Additionally oralternatively, an initial tissue stiffness measured via comparing anon-therapeutic (or quasi non-therapeutic) initial tissue compressionmeasurement and a closure member position measurement (e.g., position offirst and second jaws of end effector) could also be used in conjunctionwith the preoperative information. Ventilation preoperative informationreceived from a ventilation device in the surgical theater could furtherbe used to infer that the current procedure is thoracic. Otherpreoperative information could also be used to further predict thespecific thoracic procedure being performed. For example, based on thepatient EMR record in the cloud indicating that the patient has cancer,it could be inferred at step 22206 that the thoracic procedure is apulmonary lobectomy to excise cancerous tissue in a lung lobe.

Moreover, the patient EMR record could further indicate that the patienthistory indicates the patient has previously undergone radiationtreatments for the cancer. In this situation, it may be inferred orpredicted that the irradiated lung tissue would be stiff, but alsosusceptible to the application of monopolar RF energy by the surgicalinstrument 112, for example. This would be one example of an inferredtissue characteristic. Also, the inference that a pulmonary lobectomy isbeing performed may also be used to determine that possible tissues forstapling by the surgical instrument 112 include blood vessels (PA/PV),bronchus, and parenchyma. At step 22208, adjustments to the currentclosure algorithm are determined based on the preoperative informationand applied. As discussed above, the closure threshold and applied FTCmay be adjusted based on the tissue type and tissue characteristics. Forexample, high tissue stiffness may necessitate a slower moreconservative rate of change of applied FTC (e.g., as represented by FTClines 22012, 22112) as well as a closure threshold that generallyoutputs a lower maximum threshold (e.g., as represented by FTCL2 22010and IIFTCL2 22110).

The maximum threshold may indicate the threshold at which the first andsecond jaw members 152002, 152004 are in a sufficient position for thesurgical instrument 112 to fire staples. A relatively thicker tissue maycorrespond to a slower closure force rate of change and also a generallyhigher maximum closure threshold, for example. Also, tissue type orstructure could be inferred based on the determined surgical procedureand clinician history for identifying other closure algorithmadjustments at step 22208. For example, the treating surgeon's clinicianhistory may indicate a practice of treating blood vessels first. Itcould be inferred that the tissue type and structure is vascular lungtissue with high blood content (i.e., high vasculature). Based on thisinferred tissue type and characteristic information, it could bedetermined that adjustment to a slower applied FTC rate of change wouldbe beneficial. In sum, adjustments to the current closure algorithm aredetermined based on the inferred information and applied at step 22208.Accordingly, the current surgical operation may be performed with thesurgical instrument 112 using the adjusted current closure algorithm.

The flow diagram 22200 then proceeds to decision operation 22210, atwhich it is determined whether any steps of the identified surgicalprocedure are remaining. If there are no steps remaining (i.e., theanswer to decision operation 22210 is no), the flow diagram 22200, insome aspects, terminates. However, if the answer to decision operation22210 is yes, there are further steps of the surgical procedureremaining. Therefore, the current state of the flow diagram 22200 isintraoperation. In this case, the flow diagram proceeds to step 22212,where intraoperative information may be received and analyzed. Forexample, intraoperative information could indicate that the tissue typetreated during this step of the surgical procedure is parenchyma. Inparticular, it could be inferred that the tissue is parenchyma based onclinician history, for example. This inference could be made inconjunction with tissue contact sensor 474 measurements and load sensor474 versus closure member position measurements. Moreover, clinicianhistory may indicate that the treating surgeon routinely completes alung fissure (a double-fold of visceral pleura that folds inward tosheath lung parenchyma) after dissection with a monopolar RF energysurgical instrument In this situation, it may be inferred based on thepreviously completed monopolar RF dissection that the current step ofthe surgical procedure is lung parenchyma tissue.

Additionally, the surgical hub 106 may determine whether the surgicalinstrument 112 being used is an appropriate stapler for parenchymafirings, for example. The initial tissue contact sensor 474 measurementsmay indicate that the tissue is relatively thick, such as based ontissue contacting the length of the first and second jaw members 152002,152004 when the end effector 702 is fully open (at the maximum jawaperture), which may be consistent with parenchyma. Furthermore, theload sensor 474 versus closure member position measurements asrepresented by a closure compared to jaw aperture curve may indicaterelatively high tissue stiffness. This stiffness characteristic could beconsistent with irradiated parenchyma, which is a pre-diction that couldbe confirmed by reference to patient EMR data in the cloud. In this wayfor example at step 22212, sensor signals and perioperative informationcould be used in conjunction.

Based on this received and analyzed intraoperative information, it maybe determined at decision operation 22214, that further adjustment isnecessary. On the other hand, if the answer is no at decision operation22214, the flow diagram would proceed back to decision operation 22210.When the answer at decision operation 22214 is yes, tissue type andtissue characteristics are inferred such as determining parenchymatissue structure and stiffness characteristics, similar to as describedabove at step 22206. Subsequently, adjustments to the currently appliedclosure algorithm can be determined and applied at step 22208. Inparticular, the inference that stiff and fragile parenchyma tissue isbeing treated could cause adjustment to a slower, more conservative rateof change of applied closure force.

Accordingly, the current closure algorithm may be adjusted to analgorithm that minimizes the closure threshold and rate of change. Thatis, the adjusted threshold may have a reduced maximum closure forcethreshold, a more gradual rate of change in closure force, a reducedrate of change of closure force threshold, or some combination orsubcombination of the above. In situations in which the clinicianinadvertently exceeds the closure threshold, a wait time can beinstituted, for example. Exceeding the closure threshold may indicatethat the tissue or material being compressed is too thick for firingstaples, for example, so this wait time may be necessary.

Upon applying this modified closure algorithm to the parenchyma tissueat step 22208, the flow diagram again proceeds to decision operation22210. Here, the answer may again be yes because there are remainingsteps of the surgical procedure. For example, the lobectomy proceduremay then proceed to a vessel stapling step Again, at step 22212,intraoperative information is received and analyzed. For example, thesurgical hub could determine that the clinician has selected a vascularstapler surgical instrument. Also, an initial measurement from thetissue contact sensors 474 may indicate that tissue contact occursalmost immediately during closure. In addition, the tissue contact maybe determined to encompass a small area of the vascular stapler 112 andis bounded on the distal side of the stapler 112. Load sensor 474measurements may also indicate a compliant tissue structure. Further, itmay be inferred that the tissue may have relatively low stiffness whichmay be consistent with a lung pulmonary vessel. Moreover, clinicianhistory may indicate that the treating surgeon generally uses a vascularstapler 112 for blood vessels as the step subsequent to completing thelung fissure. Thus, intraoperative information, in conjunction withclosure parameter sensor signals for example, may be used to infertissue type and tissue characteristics. In particular, it can bepredicted that vessel tissue is being treated based on the specificcharacteristics of the selected vascular stapler 112. The initial tissuecontact and load sensor 474 measurements may confirm this initialprediction, for example.

Consequently, it can be determined at decision operation 22214 thatfurther adjustment is necessary, which causes the flow diagram 22200 toproceed to step 22206. At step 22206, it may be inferred that the tissueis blood vessel tissue with relatively low tissue thickness andstiffness. Accordingly, the flow diagram 22200 proceeds to step 22208,where the previously applied conservative closure algorithm is adjustedto a normal closure algorithm. A normal closure algorithm may comprise aconstant closure rate of change. Also, the closure threshold could behigher than the threshold used in the control algorithm for theparenchyma tissue. In other words, the normal closure algorithm mayreach a higher maximum applied closure force and the closure rate ofchange may be faster than for parenchyma tissue. The surgical instrumentcan also inform the clinician of the adjustment to the normal closurealgorithm via a suitable indicator, such as a light emitting diode (LED)indicator displaying a particular color. In another example, it could bedetermined at step 22206 that the patient has a complete lung fissure.Accordingly, there would not have been any staple firings of parenchymatissue performed yet in the surgical procedure. In response to thisdetermination, the surgical instrument may prompt the clinician forconfirmation that this inference is correct, such as via a display ofthe surgical instrument. The clinician could then manually select anappropriate closure control algorithm for this step or stage of thesurgical procedure. Additionally or alternatively, the surgicalinstrument 112 may default to a conservative closure algorithm becausethe inferences performed at step 22206 may not be definitive. In anycase, the adjusted closure algorithm is applied at step 22208.

Continuing the description of the lung lobectomy procedure example, theflow diagram proceeds to decision operation 22210. At decision operation22210, it may be determined that there are remaining steps of thesurgical procedure. Accordingly, at step 22212, intraoperativeinformation is received and analyzed. Based on intraoperativeinformation, it may be inferred that the tissue type being treated isbronchus tissue. Furthermore, the initial tissue contact sensor 474measurements could indicate that the tissue grasped between the endeffector 702 contacts the first and second jaw members 152002, 152004almost immediately during initial closure of the end effector 702 andthat such contact corresponds to a small area of the stapling surgicalInstrument 112. Also, such contact is bounded on both sides of the jawmembers 152002, 152004.

Consequently, it may be predicted that this tissue contact scenariocorresponds to bronchus tissue. As dis-cussed above, these initialtissue contact sensor 474 measurements may be non-therapeutic or quasinon-therapeutic. Furthermore, the closure load sensor 474 measurementsas represented by a closure compared to jaw aperture curve may indicatea stiff tissue structure that is consistent with bronchus tissue. Theindication by the surgical procedure history that a vascular stapler 112has already been used in the surgical procedure may also mean it islikely that parenchyma staple firings have already been performed andsignificant monopolar RF energy usage has occurred. This surgicalprocedure history considered in conjunction with clinician history, forexample, may be used to predict that the surgeon is treating bronchustissue. This prediction would be consistent with the surgeon's routinepractice of stapling the bronchus as the last step in a lobectomyprocedure. Based on analyzing this type of and other suitableintraoperative information at step 22212, it can be determined atdecision operation 22214 that further adjustment is necessary. Becausethe answer to decision operation 22214 is yes, the flow diagram proceedsto step 22206 where it is inferred that the treated tissue is bronchustissue with a normal tissue stiffness and thickness.

In one aspect, it may be easy to conclude that the treated tissue isbronchus tissue because the surgical instrument 112 is only configuredfor a specific tissue type. For example, the surgical instrument 112 mayonly be adaptable to fire staples that are used for bronchus.Conversely, the surgical instrument 112 might only be adaptable to firestaples that are used for parenchyma tissue. In that scenario, a warningmight be generated by the surgical instrument 112 because the surgeon isattempting to treat bronchus tissue with staples exclusively used forparenchyma tissue. This warning could be an auditory, visual, or someother appropriate warning. In another example, a warning may be providedby a vascular stapler 112 if the vascular stapler 112 is selected foruse with bronchus tissue. As discussed above, it may be determined basedon perioperative information that the tissue being treated is bronchustissue that the vascular stapler is contraindicated for. Similarly,other perioperative information such as closure loads and staplercartridge selection may be used to provide warnings when surgicalinstruments 112 are used for tissue types or characteristics that theyare not compatible with. As discussed above, inferences made usingperioperative information may be made in conjunction with closureparameter sensor signals In all situations, safety checks may beimplemented to ensure that the surgical instrument 112 being used issafe for the tissue being treated.

In accordance with the inferred tissue type and characteristics, at step22208, an adjustment to the current closure algorithm is made. Althoughit may be determined that a constant closure rate is suitable, theclosure rate may be adjusted to be faster or slower depending on theinferred tissue characteristics of the bronchus, for example. Theclosure threshold could be modified in the same or similar way.Moreover, the current closure algorithm may also be adjusted such thatif and when the surgical instrument 112 exceeds the instantaneouslyapplicable closure threshold, a longer wait time is automaticallyenabled or suggested. For example, this wait time for bronchus tissuemay be longer than the wait time used for parenchyma tissue. Asdiscussed above, the surgeon is informed of the selected adjustment tothe closure algorithm via the LED indicators, for example. A clinicianoverride to the longer wait time is also possible so that the surgeonmay be permitted to fire the stapler surgical instrument 112 inappropriate circumstances. The flow diagram 22200 then proceeds to step22212, where it may be determined that in one aspect, the flow diagram22200 may be implemented by the control circuit. However, in otheraspects, the flow diagram 22200 can be implemented by the surgical hub106 or cloud 104. Additionally, although steps 22204 and 22212 aredescribed in terms of preoperative information and intraoperativeinformation respectively, they are not limited in this way.Specifically, perioperative information in general may be received andanalyzed rather than specific preoperative or intraoperativeinformation. As discussed above, perioperative information encompassespreoperative, intraoperative, and postoperative information. Moreover,sensor signals may be used in conjunction with perioperative informationfor contextual and inferential closure algorithm adjustments. no furthersteps of the surgical procedure remain.

FIG. 39 illustrates a logic flow diagram of a process 25030 depicting acontrol program or a logic controller for identifying irregularities intissue distribution within an end effector 25002 of a surgicalinstrument, in accordance with at least one aspect of the presentdisclosure. In one aspect, the process 25030 is executed by a controlcircuit. In another aspect, the process 25030 can be executed by acombinational logic circuit. In yet another aspect, the process 25030can be executed by a sequential logic circuit.

The process 25030 includes receiving 25032 senor signals from sensorcircuits of a sensing circuit assembly 25471 corresponding topredetermined zones (e.g. Zone 1, Zone 2, and Zone 3) within the endeffector 25002, determining 25034 tissue impedance Z tissue of tissueportions at such zones based on the received sensor signals.

FIG. 40 illustrates a logic flow diagram of a process 25600 depicting acontrol program or a logic configuration for properly positioning apreviously-stapled tissue within an end effector (e.g. end effectors25500, 25510) of a surgical stapler. In one aspect, the process 25600 isexecuted by a control circuit. In another aspect, the process 25600 isexecuted by a combinational logic circuit In yet another aspect, theprocess 25600 is executed by a sequential logic circuit.

For illustrative purposes, the following description depicts the process25600 as being executable by a control circuit that includes acontroller 461, which includes a processor 461. A memory 468 storesprogram instructions, which are executable by the processor 461 toperform the process 25600.

The process 25600 determines 25602 the type of surgical procedure beingperformed by the surgical stapler. The surgical procedure type can bedetermined using various techniques described under the heading“Situational Awareness”. The processor 25600 then selects 25604, basedon the determined surgical procedure type, a tissue impedance signaturefor a properly positioned previously-stapled tissue. As described above,a properly positioned previously stapled tissue in a J-pouch procedure,for example, comprises a different tissue impedance signature than in anEnd-To-End Anastomosis procedure, for example.

The process 25600 then determines 25606 whether measured tissueimpedances in the predetermined zones correspond to the selected tissueimpedance signature. If not, the processor 461 may alert 25608 the userand/or override 25610 the tissue treatment. In one aspect, the processor461 may alert 25608 the user through the display 473. In addition, theprocessor 461 may override 25610 the tissue treatment by preventing theend effector from completing its firing, which can be accomplished bycausing the motor driver to stop the motor, for example.

If, however, the measured tissue impedances in the predetermined zonescorrespond to the selected tissue impedance signature, the processor 461permits the end effector to proceed 25612 with the tissue treatment.

FIG. 41 illustrates a logic flow diagram of a process 9200 for updatingthe control program of a modular device 9050, in accordance with atleast one aspect of the present disclosure. The process 9200 can beexecuted by, for example, one or more processors of the analyticsservers 9070 of the analytics system 9100. In one exemplification, theanalytics system 9100 can be a cloud computing system. For economy, thefollowing description of the process 9200 will be described as beingexecuted by the analytics system 9100; however, it should be understoodthat the analytics system 9100 includes processor(s) and/or controlcircuit(s) that are executing the describe steps of the process 9200.

The analytics system 9100 receives 9202 modular device 9050perioperative data and surgical procedural outcome data from one or moreof the surgical hubs 9000 that are communicably connected to theanalytics system 9100. The perioperative data includes preoperativedata, intraoperative data, and/or postoperative data detected by amodular device 9050 in association with a given surgical procedure. Formodular devices 9050 or particular functions of modular devices 9050that are manually controlled, the perioperative data indicates themanner in which a surgical staff member operated the modular devices9050. For modular devices 9050 or particular functions of modulardevices 9050 that are controlled by the modular devices' controlprograms, the perioperative data indicates the manner in which thecontrol programs operated the modular devices 9050. The manner in whichthe modular devices 9050 function under particular sets of conditions(either due to manual control or control by the modular devices' 9050control programs) can be referred to as the “operational behavior”exhibited by the modular device 9050. The modular device 9050perioperative data includes data regarding the state of the modulardevice 9050 (e.g., the force to fire or force to close for a surgicalstapling and cutting instrument or the power output for anelectrosurgical or ultrasonic instrument), tissue data measured by themodular device 9050 (e.g., impedance, thickness, or stiffness), andother data that can be detected by a modular device 9050. Theperioperative data indicates the manner in which the modular devices9050 were programmed to operate or were manually controlled during thecourse of a surgical procedure because it indicates how the modulardevices 9050 functioned in response to various detected conditions.

The surgical procedural outcome data includes data pertaining to anoverall outcome of a surgical procedure (e.g., whether there was acomplication during the surgical procedure) or data pertaining to anoutcome of a specific step within a surgical procedure (e.g., whether aparticular staple line bled or leaked). The procedural outcome data can,for example, be directly detected by the modular devices 9050 and/orsurgical hub 9000 (e.g., a medical imaging device can visualize ordetect bleeding), determined or inferred by a situational awarenesssystem of the surgical hub 9000 as described in U.S. Patent PublicationNo. 2019/0201140 A1 by the surgical hub 9000 or the analytics system9100. The procedural outcome data can include whether each outcomerepresented by the data was a positive or negative result. Whether eachoutcome was positive or negative can be determined by the modulardevices 9050 themselves and included in the pen-operative datatransmitted to the surgical hubs 9000 or determined or inferred by thesurgical hubs 9000 from the received perioperative data. For example,the procedural outcome data for a staple line that bled could includethat the bleeding represented a negative outcome. Similarly, theprocedural outcome data for a staple line that did not bleed couldinclude that the lack of bleeding represented a positive outcome. Inanother exemplification, the analytics system 9100 can be configured todetermine whether a procedural outcome is a positive or negative outcomebased upon the received procedural outcome data. In someexemplifications, correlating the modular device 9050 data to positiveor negative procedural outcomes allows the analytics system 9100 todetermine whether a control program update should be generated 9208.

Upon the analytics system 9100 receiving 9202 the data, the analyticssystem 9100 analyzes the modular device 9050 and procedural outcome datato determine 9204 whether the modular devices 9050 are being utilizedsuboptimally in connection with the particular procedure or theparticular step of the procedure. A modular device 9050 can becontrolled suboptimally if the particular manner in which the modulardevice 9050 is being controlled is repeatedly causing an error or if analternative manner of controlling the modular device 9050 is superiorunder the same conditions. The analytics system 9100 can thus determinewhether a modular device 9050 is being controlled suboptimally (eithermanually or by its control program) by comparing the rate of positiveand/or negative outcomes produced by the modular device 9050 relative toset thresholds or the performance of other modular devices 9050 of thesame type.

For example, the analytics system 9100 can determine whether a type ofmodular device 9050 is being operated suboptimally if the rate ofnegative procedural outcomes produced by the modular device 9050 under aparticular set of conditions in association with a particularoperational behavior exceeds an average or threshold level. As aspecific example, the analytics system 9100 can analyze 9204 whether acontrol program for a surgical stapling instrument that dictates aparticular force to fire (or ranges of forces to fire) is suboptimal fora particular tissue thickness and tissue type. If the analytics system9100 determines that the instrument generates an abnormally high rate ofleaky staple lines when fired at the particular force (e.g., causing thestaples to be malformed, not fully penetrate the tissue, or tear thetissue) relative to an average or threshold staple line leakage rate,then the analytics system 9100 can determine that the control programfor the surgical stapling instrument is performing suboptimally giventhe tissue conditions.

As another example, the analytics system 9100 can determine whether atype of modular device 9050 is being operated suboptimally if the rateof positive outcomes produced by an alternative manner of control undera particular set of conditions in association with a particularoperational behavior exceeds the rate of positive outcomes generated bythe analyzed manner of control under the same conditions. In otherwords, if one subpopulation of the type of modular device 9050 exhibitsa first operational behavior under a certain set of conditions and asecond subpopulation of the same type of modular device 9050 exhibits asecond operational behavior under the same set of conditions, then theanalytics system 9100 can determine whether to update the controlprograms of the modular devices 9050 according to whether the first orsecond operational behavior is more highly correlated to a positiveprocedural outcome. As a specific example, the analytics system 9100 cananalyze 9204 whether a control program for an RF electrosurgical orultrasonic instrument that dictates a particular energy level issuboptimal for a particular tissue type and environmental conditions. Ifthe analytics system 9100 determines that a first energy level given aset of tissue conditions and environmental conditions (e.g., theinstrument being located in a liquid-filled environment, as in anarthroscopic procedure) produces a lower rate of hemostasis than asecond energy level, then the analytics system 9100 can determine thatthe control program for the electrosurgical or ultrasonic instrumentdictating the first energy level is performing suboptimally for thegiven tissue and environmental conditions.

After analyzing 9204 the data, the analytics system 9100 determines 9206whether to update the control program. If the analytics system 9100determines that the modular device 9050 is not being controlledsuboptimally, then the process 9200 continues along the NO branch andthe analytics system 9100 continues analyzing 9204 received 9202 data,as described above. If the analytics system 9100 determines that themodular device 9050 is being controlling suboptimally, then the process9200 continues along the YES branch and the analytics system 9100generates 9208 a control program update. The generated 9208 controlprogram update includes, for example, a new version of the controlprogram for the particular type of modular device 9050 to overwrite theprior version or a patch that partially overwrites or supplements theprior version.

The type of control program update that is generated 9208 by theanalytics system 9100 depends upon the particular suboptimal behaviorexhibited by the modular device 9050 that is identified by the analyticssystem 9100. For example, if the analytics system 9100 determines that aparticular force to fire a surgical stapling instrument results in anincreased rate of leaking staple lines, then the analytics system 9100can generate 9208 a control program update that adjusts the force tofire from a first value to a second value that corresponds to a higherrate of non-leaking staple lines or a lower rate of leaking staplelines. As another example, if the analytics system 9100 determines thata particular energy level for an electrosurgical or ultrasonicinstrument produces a low rate of hemostasis when the instrument is usedin a liquid-filled environment (e.g., due to the energy dissipatingeffects of the liquid), then the analytics system 9100 can generated9208 a control program update that adjusts the energy level of theinstrument when it is utilized in surgical procedures where theinstrument will be immersed in liquid.

The type of control program update that is generated 9208 by theanalytics system 9100 also depends upon whether the suboptimal behaviorexhibited by the modular device 9050 is caused by manual control orcontrol by the control program of the modular device 9050. If thesuboptimal behavior is caused by manual control, the control programupdate can be configured to provide warnings, recommendations, orfeedback to the users based upon the manner in which they are operatingthe modular devices 9050. Alternatively, the control program update canchange the manually controlled operation of the modular device 9050 toan operation that is controlled by the control program of the modulardevice 9050. The control program update may or may not permit the userto override the control program's control of the particular function. Inone exemplification, if the analytics system 9100 determines 9204 thatsurgeons are manually setting an RF electrosurgical instrument to asuboptimal energy level for a particular tissue type or procedure type,then the analytics system 9100 can generate 9208 a control programupdate that provides an alert (e.g., on the surgical hub 9000 or the RFelectrosurgical instrument itself) recommending that the energy level bechanged. In another exemplification, the generated 9208 control programupdate can automatically set the energy level to a default orrecommended level given the particular detected circumstances, whichcould then be changed as desired by the medical facility staff. In yetanother exemplification, the generated 9208 control program update canautomatically set the energy level to a set level determined by theanalytics system 9100 and not permit the medical facility staff tochange the energy level. If the suboptimal behavior is caused by thecontrol program of the modular device 9050, then the control programupdate can alter how the control program functions under the particularset of circumstances that the control program is performing suboptimallyunder.

Once the control program update has been generated 9208 by the analyticssystem 9100, the analytics system 9100 then transmits 9210 or pushes thecontrol program update to all of the modular devices 9050 of therelevant type that are connected to the analytics system 9100. Themodular devices 9050 can be connected to the analytics system 9100through the surgical hubs 900, for example. In one exemplification, thesurgical hubs 9000 are configured to download the control programupdates for the various types of modular devices 9050 from the analyticssystem 9100 each time an update is generated 9208 thereby. When themodular devices 9050 subsequently connect to or pair with a surgical hub9000, the modular devices 9050 then automatically download any controlprogram updates therefrom. In one exemplification, the analytics system9100 can thereafter continue receiving 9202 and analyzing 9204 data fromthe modular devices 9050, as described above.

In one aspect, the surgical system 9060 is configured to push downverification of software parameters and updates if modular devices 9050are detected to be out of date in the surgical hub 9000 data stream.FIG. 42 illustrates a diagram of an analytics system 9100 pushing anupdate to a modular device 9050 through a surgical hub 9000, inaccordance with at least one aspect of the present disclosure. In oneexemplification, the analytics system 9000 is configured to transmit agenerated control program update for a particular type of modular device9050 to a surgical hub 9000. In one aspect, each time a modular device9050 connects to a surgical hub 9000, the modular device 9050 determineswhether there is an updated version of its control program on orotherwise accessible via the surgical hub 900). If the surgical hub 9000does have an updated control program (or the updated control program isotherwise available from the analytics system 9100) for the particulartype of modular device 9050, then the modular device 9050 downloads thecontrol program update therefrom.

In one exemplification, any data set being transmitted to the analyticssystems 9100 includes a unique ID for the surgical hub 9000 and thecurrent version of its control program or operating system. In oneexemplification, any data set being sent to the analytics systems 9100includes a unique ID for the modular device 9050 and the current versionof its control program or operating system. The unique ID of thesurgical hub 9000 and/or modular device 9050 being associated with theuploaded data allows the analytics system 9100 to determine whether thedata corresponds to the most recent version of the control program. Theanalytics system 9100 could, for example, elect to discount (or ignore)data generated by a modular device 9050 or surgical hub 9000 beingcontrolled by an out of date control program and/or cause the updatedversion of the control program to be pushed to the modular device 9050or surgical hub 9000.

In one exemplification, the operating versions of all modular devices9050 the surgical hub 9000 has updated control software for could alsobe included in a surgical hub 9000 status data block that is transmittedto the analytics system 9100 on a periodic basis. If the analyticssystem 9100 identifies that the operating versions of the controlprograms of the surgical hub 9100 and/or any of the connectable modulardevices 9050 are out of date, the analytics system 9100 could push themost recent revision of the relevant control program to the surgical hub9000.

In one exemplification, the surgical hub 9000 and/or modular devices9050 can be configured to automatically download any software updates.In another exemplification, the surgical hub 9000 and/or modular devices9050 can be configured to provide a prompt for the user to ask at thenext setup step (e.g., between surgical procedures) if the user wants toupdate the out of date control program(s). In another exemplification,the surgical hub 9000 could be programmable by the user to never allowupdates or only allow updates of the modular devices 9050 and not thesurgical hub 9000 itself.

FIG. 43 illustrates a diagram of a computer-implemented adaptivesurgical system 9060 that is configured to adaptively generate controlprogram updates for surgical hubs 9000, in accordance with at least oneaspect of the present disclosure. The surgical system 9060 includesseveral surgical hubs 900) that are communicably coupled to theanalytics system 9100. Subpopulations of surgical hubs 9000 (each ofwhich can include individual surgical hubs 9000 or groups of surgicalhubs 9000) within the overall population connected to the analyticssystem 9100 can exhibit different operational behaviors during thecourse of a surgical procedure. The differences in operational behaviorbetween groups of surgical hubs 9000 within the population can resultfrom the surgical hubs 9000 running different versions of their controlprogram, by the surgical hubs' 9000 control programs being customized orprogrammed differently by local surgical staff, or by the local surgicalstaff manually controlling the surgical hubs 9000 differently. In thedepicted example, the population of surgical hubs 9000 includes a firstsubpopulation 9312 that is exhibiting a first operational behavior and asecond subpopulation 9314 that is exhibiting a second operationalbehavior for a particular task. Although the surgical hubs 9000 aredivided into a pair of subpopulations 9312, 9314 in this particularexample, there is no practical limit to the number of differentbehaviors exhibited within the population of surgical hubs 9000. Thetasks that the surgical hubs 9000 can be executing include, for example,controlling a surgical instrument or analyzing a dataset in a particularmanner.

The surgical hubs 9000 can be configured to transmit perioperative datapertaining to the operational behavior of the surgical hubs 9000 to theanalytics system 9100. The perioperative data can include preoperativedata, intraoperative data, and postoperative data. The preoperative datacan include, for example, patient-specific information, such asdemographics, health history, preexisting conditions, preoperativeworkup, medication history (i.e., medications currently and previouslytaken), genetic data (e.g., SNPs or gene expression data), EMR data,advanced imaging data (e.g., MRI, CT, or PET), metabolomics, andmicrobiome. Various additional types of patient-specific informationthat can be utilized by the analytics system 9100 are described by U.S.Pat. No. 9,250,172, U.S. patent application Ser. No. 13/631,095, U.S.patent application Ser. No. 13/828,809, and U.S. Pat. No. 8,476,227,each of which is incorporated by reference herein to the extent thatthey describe patient specific information. The preoperative data canalso include, for example, operating theater-specific information, suchas geographic information, hospital location, operating theaterlocation, operative staff performing the surgical procedure, theresponsible surgeon, the number and type of modular devices 9050 and/orother surgical equipment that could potentially be used in theparticular surgical procedure, the number and type of modular devices9050 and/or other surgical equipment that are anticipated to be used inthe particular surgical procedure, patient identification information,and the type of procedure being performed.

The intraoperative data can include, for example, modular device 9050utilization (e.g., the number of firings by a surgical staplinginstrument, the number of firings by an RF electrosurgical instrument oran ultrasonic instrument, or the number and types of stapler cartridgesutilized), operating parameter data of the modular devices 9050 (e.g.,the FT curve for a surgical stapling instrument, a FTC curve for asurgical stapling instrument, the energy output of a generator, theinternal pressure or pressure differential of a smoke evacuator),unexpected modular device 9050 utilization (i.e., the detection of theutilization of a modular device that is nonstandard for the proceduretype), adjunctive therapies administered to the patient, and utilizationof equipment other than the modular devices 9050 (e.g., sealants toaddress leaks). The intraoperative data can also include, for example,detectable misuse of a modular device 9050 and detectable off-label useof a modular device 9050.

The postoperative data can include, for example, a flag if the patientdoes not leave the operating theater and/or is sent for nonstandardpostoperative care (e.g., a patient undergoing a routine bariatricprocedure is sent to the ICU after the procedure), a postoperativepatient evaluation relating to the surgical procedure (e.g., datarelating to a spirometric performance after a thoracic surgery or datarelating to a staple line leakage after bowel or bariatric procedures),data related to postoperative complications (e.g., transfusions or airleaks), or the patient's length of stay in the medical facility afterthe procedure. Because hospitals are increasingly being graded onreadmission rates, complication rates, average length of stay, and othersuch surgical quality metrics, the postoperative data sources can bemonitored by the analytics system 9100 either alone or in combinationwith surgical procedural outcome data (discussed below) to assess andinstitute updates to the controls programs of the surgical hubs 9000and/or modular devices 9050.

In some exemplifications, the intraoperative and/or postoperative datacan further include data pertaining to the outcome of each surgicalprocedure or a step of the surgical procedure. The surgical proceduraloutcome data can include whether a particular procedure or a particularstep of a procedure had a positive or negative outcome. In someexemplifications, the surgical procedural outcome data can includeprocedure step and/or time stamped images of modular device 9050performance, a flag indicating whether a modular device 9050 functionedproperly, notes from the medical facility staff, or a flag for poor,suboptimal, or unacceptable modular device 9050 performance. Thesurgical procedural outcome data can, for example, be directly detectedby the modular devices 9050 and/or surgical hub 9000 (e.g., a medicalimaging device can visualize or detect bleeding), determined or inferredby a situational awareness system of the surgical hub 9000 as describedin U.S. Patent Publication No. 2019/0201140 A1 by the surgical hub 900)or the analytics system 9100. In some exemplifications, perioperativedata including a flag indicating that a modular device 9050 failed orotherwise performed poorly during the course of a surgical procedure canbe prioritized for communication to and/or analysis by the analyticssystem 9100.

In one exemplification, the perioperative data can be assembled on aprocedure-by-procedure basis and uploaded by the surgical hubs 9000 tothe analytics system 9100 for analysis thereby. The perioperative dataindicates the manner in which the surgical hubs 9000 were programmed tooperate or were manually controlled in association with a surgicalprocedure (i.e., the operational behavior of the surgical hubs 9000)because it indicates what actions the surgical hub 9000J took inresponse to various detected conditions, how the surgical hubs 9000controlled the modular devices 9050, and what inferences thesituationally aware surgical hubs 9000 derived from the received data.The analytics system 9100 can be configured to analyze the various typesand combinations of preoperative, intraoperative, and post-operativedata to determine whether a control program update should be generatedand then push the update to the overall population or one or moresub-populations of surgical hubs 9000, as necessary.

FIG. 44 illustrates a logic flow diagram of a process 9300 for updatingthe control program of a surgical hub 9000, in accordance with at leastone aspect of the present disclosure. The process 9200 can be executedby, for example, one or more processors of the analytics servers 9070 ofthe analytics system 9100. In one exemplification, the analytics system9100 can be a cloud computing system. For economy, the followingdescription of the process 9300 will be described as being executed bythe analytics system 9100; however, it should be understood that theanalytics system 9100 includes processor(s) and/or control circuit(s)that are executing the describe steps of the process 9300.

The analytics system 9100 executing the process 9300 receives 9302perioperative data from the surgical hubs 9000 that are communicablyconnected to the analytics system 9100. The perioperative data indicatesthe manner in which the surgical hubs 9000 are programmed to operate bytheir control programs or are controlled by the surgical staff during asurgical procedure. In some aspects, the perioperative data can includeor being transmitted to the analytics system 9100 in association withsurgical procedural out-come data. The surgical procedural outcome datacan include data pertaining to an overall outcome of a surgicalprocedure e.g., whether there was a complication during the surgicalprocedure) or data pertaining to a specific step within a surgicalprocedure (e.g., whether a particular staple line bled or leaked).

After an analytics system 9100 executing the process 9300 has received9302 the perioperative data, the analytics system 9100 then analyzes9304 the data to determine whether an update condition has beensatisfied. In one exemplification, the update condition includes whethera threshold number or percentage of surgical hubs 9000 within thepopulation exhibit a particular operational behavior. For example, theanalytics system 9100 can determine that a control program update shouldbe generated to automatically active an energy generator at a particularstep in a type of surgical procedure when a majority of the surgicalhubs 9000 are utilized to active the energy generator at that proceduralstep. In another exemplification, the update condition includes whetherthe rate of positive procedural outcomes (or lack of negative proceduraloutcomes) correlated to a particular operational behavior exceeds athreshold value (e.g., an average rate of positive procedural outcomesfor a procedure step). For example, the analytics system 9100 candetermine that a control program update should be generated to recommendthat the energy generator be set at a particular energy level when theassociated rate of hemostasis (i.e., lack of bleeding) at that energylevel for the particular tissue type exceeds a threshold rate. Inanother exemplification, the update condition includes whether the rateof positive procedural outcomes (or lack of negative proceduraloutcomes) for a particular operational behavior is higher than the rateof positive procedural outcomes (or a lack of negative proceduraloutcomes) for related operational behaviors. In other words, if onesubpopulation of surgical hubs 9000 exhibits a first operationalbehavior under a certain set of conditions and a second subpopulation ofsurgical hubs 9000 exhibits a second operational behavior under the sameset of conditions, then the analytics system 9100 can determine whetherto update the control programs of the surgical hubs 9000 according towhether the first or second operational behavior is more highlycorrelated to a positive procedural outcome. In another exemplification,the analytics system 9100 analyzes 9304 the data to determine whethermultiple update conditions have been satisfied.

If an update condition has not been satisfied, the process 9300continues along the NO branch and the analytics system 9100 continuesreceiving 9302 and analyzing 9304 perioperative data from the surgicalhubs 9000 to monitor for the occurrence of an update condition. If anupdate condition has been satisfied, the process 9300 continues alongthe YES branch and the analytics system 9100 proceeds to generate 9308 acontrol program update. The nature of the generated 9308 control programupdate corresponds to the particular operational behavior of thesurgical hub 9000 that is identified by the analytics system 9100 astriggering the update condition. In other words, the control programupdate adds, removes, or otherwise alters functions performed by thesurgical hub 9000 so that the surgical hub operates differently underthe conditions that gave rise to the identified operational behavior.

Furthermore, the type of control program update also depends uponwhether the identified operational behavior results from manual controlor control by the control program of the surgical hub 9000. If theidentified operational behavior results from manual control, the controlprogram update can be configured to provide warnings, recommendations,or feedback to the users based upon the manner in which they areoperating the surgical hub 9000. For example, if the analytics system9100 determines that taking a particular action or utilizing aparticular instrument for a step in a surgical procedure improvesoutcomes, then the analytics system 9100 can generate 9308 a controlprogram update that provides a prompt or warning to the surgical staffwhen the surgical hub 9000 determines that the designated step of thesurgical procedure is occurring or will subsequently occur.Alternatively, the control program update can change one or morefunctions of the surgical hub 9000 from being manually controllable tobeing controlled by the control program of the surgical hub 9000. Forexample, if the analytics system 9100 determines that a display of thevisualization system is set to a particular view by the surgical staffin a predominant number of surgical procedures at a particular step, theanalytics system 9100 can generate a control program update that causesthe surgical hub 9000 to automatically change the display to that viewunder those conditions. If the identified operational behavior resultsfrom the control program of the surgical hub 9000, then the controlprogram update can alter how the control program functions under the setof circumstances that cause the identified operational behavior. Forexample, if the analytics system 9100 determines that a particularenergy level for an RF electrosurgical or ultrasonic instrumentcorrelates to poor or negative outcomes under a certain set ofconditions, then the analytics system 9100 can generate 9308 a controlprogram update that causes the surgical hub 9000 to adjust the energylevel of the connected instrument to a different value when the set ofconditions is detected (e.g., when the surgical hub 9000 determines thatan arthroscopic procedure is being performed).

The analytics system 9100 then transmits 9310 the control program updateto the overall population of surgical hubs 9000 or the subpopulation(s)of surgical hubs 9000 that are performing the operational behavior thatis identified by the analytics system 9100 as triggering the updatecondition. In one exemplification, the surgical hubs 9000 are configuredto download the control program updates from the analytics system 9100each time an update is generated 9308 thereby. In one exemplification,the analytics system 9100 can thereafter continue the process 9300 ofanalyzing 9304 the data received 9302 from the surgical hubs 9000, asdescribed above.

FIG. 45 illustrates a representative implementation of the process 9300depicted in FIG. 44. FIG. 45 illustrates a logic flow diagram of aprocess 9400 for updating the data analysis algorithm of a controlprogram of a surgical hub 9000, in accordance with at least one aspectof the present disclosure. As with the process 9300 depicted in FIG. 44,the process 9400 illustrated in FIG. 45 can, in one exemplification, beexecuted by the analytics system 9100. In one exemplification of theadaptive surgical system 9060 depicted in FIG. 43, the first surgicalhub subpopulation 9312 is utilizing a first data analysis algorithm andthe second surgical hub subpopulation 9314 is utilizing a second dataanalysis algorithm. For example, the first surgical hub subpopulation9312 can be utilizing a normal continuous probability distribution toanalyze a particular dataset, whereas the second surgical hubsubpopulation 9314 can be utilizing a bimodal distribution for analyzingthe particular dataset. In this exemplification, the analytics system9100 receives 9402, 9404 the perioperative data from the first andsecond surgical hub subpopulations 9312, 9314 corresponding to therespective data analysis algorithms. The analytics system 9100 thenanalyzes 9406 the perioperative datasets to determine whether one of theperioperative datasets satisfies one or more update conditions. Theupdate conditions can include, for example, a particular analysis methodbeing utilized by a threshold percentage (e.g., 75%) of the surgicalhubs 9000 in the overall population and a particular analysis methodbeing correlated to positive surgical procedural outcomes in a thresholdpercentage (e.g., 50%) of cases.

In this exemplification, the analytics system 9100 determines 9408whether one of the data analysis algorithms utilized by the first andsecond surgical hub subpopulations 9312, 9314 satisfies both of theupdate conditions. If the update conditions are not satisfied, then theprocess 9400 proceeds along the NO branch and the analytics system 9100continues receiving 9402, 9404 and analyzing 9406 perioperative datafrom the first and second surgical hub subpopulations 9312, 9314. If theupdate conditions are satisfied, the process 9400 proceeds along the YESbranch and the analytics system 9100 generates 9412 a control programupdate according to which of the data analysis algorithms the analysis9406 determined satisfied the update conditions. In thisexemplification, the control program update would include causing thesurgical hub 9000 to utilize the data analysis algorithm that satisfiedthe update conditions when performing the corresponding analysis type.The analytics system 9100 then transmits 9414 the generated 9412 controlprogram update to the population of surgical hubs 9000. In oneexemplification, the control program update is transmitted 9414 to theentire population of surgical hubs 9000. In another exemplification, thecontrol program update is transmitted 9414 to the subpopulation ofsurgical hubs 9000 that did not utilize the data analysis algorithm thatsatisfied the update conditions. In other words, if the analytics system9100 analyzes 9406 the perioperative data and determines 9408 that thesecond (bimodal) data analysis method satisfies the update conditions,then the generated 9412 control program update is transmitted 9414 tothe first subpopulation of surgical hubs 9000 in this exemplification.Furthermore, the control program update can either force the updatedsurgical hubs 9000 to utilize the second (bimodal) data analysisalgorithm when analyzing the particular dataset or cause the updatedsurgical hubs 9000 to provide a warning or recommend to the user thatthe second (bimodal) data analysis algorithm be used under the givenconditions (allowing the user to choose whether to follow therecommendation).

This technique improves the performance of the surgical hubs 9000 byupdating their control programs generated from data aggregated acrossthe entire network of surgical hubs 9000. In effect, each surgical hub9000 can be adjusted according to shared or learned knowledge across thesurgical hub 9000 network. This technique also allows the analyticssystem 9100 to determine when unexpected devices (e.g., modular devices9050) are utilized during the course of a surgical procedure byproviding the analytics system 9100 with knowledge of the devices beingutilized in each type of surgical procedure across the entire surgicalhub 9000 network.

FIG. 46 illustrates a system 46000 for communication between a poweredsurgical end-effector 46002, a surgical hub 46004, and a cloud computingsystem 46006, in accordance with at least one aspect of the presentdisclosure. The powered surgical end-effector 46002 may include atransmitter 46008 and a receiver 46010 that may be configured toestablish communication pathways 46012 and 46014 between at least oneexternal device. For example, the communication pathway 46012 may bebetween the powered surgical end-effector 46002 and the surgical hub46004 and the communication pathway 46014 may be between the poweredsurgical end-effector 46002 and the cloud-computing system 46006. Thepowered-surgical end-effector 46002 may include a controllable jaw 46016that may be configured to operate on a tissue. The controllable jaw46016 may include a first jaw and a second jaw. The tissue to beoperated on may be positioned between the first and second jaws and maybe clamped by the first and second jaws closing together. The poweredsurgical end-effector 46002 may include an updatable memory 46018 thatmay have stored data including a default actuation algorithm 46020. Thepowered surgical end-effector 46002 may include a processor 46022 thatmay be configured to operate the default actuation algorithm 46020. Thedefault actuation algorithm 46020 may be configured to operate an aspectof the controllable jaw 46016. The processor 46022 may update thedefault actuation algorithm 46020. The default actuation algorithm 46020may perform a set of operations based on input data received about thecontrollable jaw 46016. The default actuation algorithm 46020 maytransmit the input data into output signals. For example, the input datareceived about an aspect of the controllable jaw 46020 may relate to aclamp pressure, a hold time, and/or a fire speed of the controllable jaw46020. For example, the input data received may relate to procedureinformation, properties of the tissue, and/or to supplementarymeasurements. For example, the supplementary measurements may bedetermined through situational awareness, as described above. Forexample, the supplementary measurements may also be determined byhospital inputs and/or by user inputs. The default control algorithm46020 may include algorithms described above, such as the algorithm23200 (FIG. 36), the closure algorithms (FIG. 38), and the data analysisalgorithms (FIG. 45).

The surgical hub 46004 may include a transmitter 46026 and a receiver46028. The transmitter 46026 and/or the receiver 46028 may be configuredto establish the communication pathways between the surgical hub 46004and at least one external device. For example, the communication pathway46012 may be between the surgical hub 46004 and the surgicalend-effector 46002. A communication pathway 46024 may be between thesurgical hub 46004 and the cloud-computing system 46006. The surgicalhub 46004 may include data that includes a control algorithm 46030. Thesurgical hub 46004 may include a processor 46032 that is configured toreceive and interpret data.

FIG. 47 illustrates a logic flow diagram of a process 47000 for updatingthe algorithm of a surgical instrument, in accordance with at least oneaspect of the present disclosure. At 47002, the process 47000 mayconfigure the powered surgical end-effector 46002 to operate in a firstmode and at a first time. The first mode may be configured to operate anaspect of the controllable jaw 46016 according to the default actuationalgorithm 46020 stored in the updatable memory 46018 of the poweredsurgical end-effector 46002. At 47004, the process 47000 may determinewhether the powered surgical end-effector 46002 receives data at asecond time after the first tune. If no, at 47006, the process 47000 maycontinue to operate in the first mode. If yes, at 47008, the receiveddata may automatically cause the powered surgical end-effector 46002 tochange from operating in a first mode to operating in a second mode. Thereceived data may be received from an external source via the receiver46010 of the powered surgical end-effector 46004. For example, externalsource can be the surgical hub 46004 and/or the cloud computing system46006. The received data may relate to procedure information, propertiesof the tissue, and/or to supplementary measurements. For example, thesupplementary measurements may be determined through situationalawareness, as described above. For example, the supplementarymeasurements may also be determined by hospital inputs and/or by userinputs. The second mode may be configured to operate an aspect of thecontrollable jaw 46016 according to an alternative actuation algorithm.The aspect of the controllable jaw 46016 that may be updated may relateto clamp pressure, a hold time, and/or a fire speed of the aspect of thecontrollable jaw 46016, for example. The actuation algorithm may beupdated from the default actuation algorithm 46020 to the alternativeactuation algorithm using the process 9300 described above in FIGS.44-45 for updating the control algorithm.

FIG. 48 illustrates a logic flow diagram of a process 48000 for updatingthe algorithm of a surgical instrument, in accordance with at least oneaspect of the present disclosure. At 48002, the powered surgicalend-effector 46002 is configured to obtain the default actuationalgorithm 46020 and the alternative actuation algorithm. The defaultactuation algorithm 46020 may be correspond to data stored m theupdatable memory 46018 of the powered surgical end-effector 46002. Thedefault actuation algorithm 46020 may cause the powered surgicalend-effector 46002 to operate an aspect of the controllable jaw 46016according to a first mode. The default actuation algorithm 46020 and thealternative actuation algorithm may be obtained as described above inFIGS. 42-45. Some examples of the aspects of the controllable jaw 46016may be a clamp pressure, a hold time, and/or a fire speed of the aspectof the controllable jaw 46016, for example. The alternative actuationalgorithm may correspond to data received from an external source. Forexample, the external source may be the surgical hub 46004 and/or thecloud computing system 46006. The alternative actuation algorithm maycause the powered surgical end-effector 46002 to operate an aspect ofthe controllable jaw according to a second mode. At 48004, the poweredsurgical end-effector 46002 determines whether or not it should operateaccording to the first mode, which may act as a default mode. Thedetermination may be based on procedure information, properties of thetissue, and/or to supplementary measurements. For example, thesupplementary measurements may be determined through situationalawareness, as described above. For example, the supplementarymeasurements may also be determined by hospital inputs and/or by userinputs. If yes at 48004, at 48036, the powered surgical end-effector46002 may operate in the first mode. At 48008, the powered surgicalend-effector 46002 determines whether or not it should operate accordingto the second mode, which may act as an alternative mode. Thedetermination may be based on procedure information, properties of thetissue, and/or to supplementary measurements. For example, thesupplementary measurements may be determined through situationalawareness, as described above. For example, the supplementarymeasurements may also be determined by hospital inputs and/or by userinputs. If yes to 48008, at 48010, the powered surgical end-effector46002 may change from operating in the first mode to operating in thesecond mode according to the alternative actuation algorithm. Theactuation algorithm may be updated from the default actuation algorithm46020 to the alternative actuation algorithm using the process 9300described above in FIGS. 44-45 for updating the control algorithm. If noto 48008, at 48012, the powered surgical end-effector 46002 may continueoperating in the first mode, which may the default mode.

FIG. 49 illustrates a logic flow diagram of a process 49000 for updatingthe algorithm of a surgical instrument, in accordance with at least oneaspect of the present disclosure. At 49002, the powered surgicalend-effector 46002 is configured to obtain a default actuation algorithmand an alternative actuation algorithm. The default actuation algorithmmay be correspond to data stored in the updatable memory 46018 of thepowered surgical end-effector 46002. The default actuation algorithm maycause the powered surgical end-effector 46002 to operate an aspect ofthe controllable jaw 46016 according to a first mode. Some examples ofthe aspects of the controllable jaw 46016 may be a clamp pressure, ahold time, and/or a fire speed of the aspect of the controllable jaw46016, for example. The alternative actuation algorithm may correspondto data received from an external source. For example, the externalsource can be the surgical hub 46004 and/or the cloud computing system46006. The alternative actuation algorithm may cause the poweredsurgical end-effector 46002 to operate an aspect of the controllable jaw46016 according to a second mode. At 49004, the powered surgicalend-effector 46002 determines whether it should operate in the firstmode or operate in the second mode. The determination may be based ondata received regarding procedure information, properties of the tissue,and/or to supplementary measurements. For example, the supplementarymeasurements may be determined through situational awareness, asdescribed above. For example, the supplementary measurements may also bedetermined by hospital inputs and/or by user inputs. At 49006, thepowered surgical end-effector 46002 may operate in the first mode if itdetermines it should operate in the first mode at 49004. At 49008, thepowered surgical end-effector 46002 may operate in the second modeaccording to the alternative actuation algorithm if it determines itshould operate in the second mode at 49004. The actuation algorithm maybe updated from the default actuation algorithm 46020 to the alternativeactuation algorithm using the process 9300 described above in FIGS.44-45 for updating the control algorithm.

FIG. 50 illustrates a logic flow diagram of a process 50000 for asurgical hub updating an algorithm of a surgical instrument, inaccordance with at least one aspect of the present disclosure. At 50002,the surgical hub 46004 may seek communication with the powered surgicalend-effector 46002. The surgical hub 46004 may seek communication bysending a communication request to the powered surgical end-effector46002. At 50004, the surgical hub 46004 may determine whethercommunication is available with the powered surgical end-effector 46002that may be configured to operate in a first mode or in a second mode.The determination whether communication is available may be determinedby an available processing capacity, a memory, a bandwidth, a softwarerevision, and/or a subscription level, for example. If communication isnot available, the process 50000 may go back to 50002 and the surgicalhub 46004 may seek communication with the powered surgical end-effector46002. If communication is available, at 50006, the surgical hub 46004may receive data from the powered surgical end-effector 46002 via thereceiver 46028 and then upload the received data. At 50008, the surgicalhub 46004 may determine whether the surgical end-effector 46002 shouldoperate in the first mode or the second mode based on the received data.The determination may be based on received data. The received data maybe based on procedure information, properties of the tissue, and/or tosupplementary measurements. For example, the supplementary measurementsmay be determined through situational awareness, as described above. Forexample, the supplementary measurements may also be determined byhospital inputs and/or by user inputs. If the surgical hub 46004determines it should operate in a first mode, the process 50000 may goback to 50006 and receive updated data from the powered surgicalend-effector 46002 at the later time via the receiver 46028 and thenupload the updated received data. If the surgical hub 46004 determinesit should operate in a second mode, then at 501, based on thedetermination, the surgical hub 46004 may send updated data that causesthe powered surgical end-effector 46002 to operate in the second mode.In the second mode, the powered surgical end-effector 46002 may operatethe aspect of the controllable jaw 46016 according to an alternativeactuation algorithm. The actuation algorithm may be updated from thedefault actuation algorithm 46020 to the alternative actuation algorithmusing the process 9300 described above in FIGS. 44-45 for updating thecontrol algorithm.

In one aspect, the surgical hub 46004 can be connected to or paired witha variety of surgical devices, such as surgical instruments, generators,smoke evacuators, and/or displays. Through their connections to thesesurgical devices, the surgical hub 46004 may receive an array ofperioperative data from these paired surgical devices while the devicesare in use during a surgical procedure. The data can provide feed-backto the surgical staff members in real time during the surgicalprocedure. The real-time feedback can include a graphical notificationand/or recommendation displayed on a display, audio feedback emitted bythe surgical hub 46004 and/or the powered surgical end-effector 46002.The updated data may update algorithms of the powered surgicalend-effector 46002 based on use m real time and adjust the algorithmswith each action. For example, impedance within the powered surgicalend-effector 46002 can indicate what the tissue properties are forspecific patients, based on received information the powered surgicalend-effector 46002 communicates to the surgical hub 46004. The surgicalhub 46004 may then alert the powered surgical end-effector 46002 that analgorithm update is coming and update aspects of the controllable jaw46016 in real time based on the tissue properties. Examples of aspectsof the controllable jaw 46016 may be clamp pressure, hold time, and/orfire speed.

In another example, the surgical hub 46004 can provide postoperativefeedback to the surgical staff members. The postoperative feedback caninclude graphical overlays or notifications displayed on the capturedvideo of the procedure that can be reviewed by the surgical staff forlearning purposes, a post-surgery report indicating times or/orparticular surgical steps where the surgical staff deviated from thebaselines. Any visually identifiable physical characteristic (orcombination of physical characteristics) can be utilized as the basisfor suggesting improvements in the technique exhibited by the surgicalstaff.

We claim:
 1. A powered surgical end-effector, comprising: a controllablejaw configured to operate on a tissue; an updatable memory having storedtherein a default actuation algorithm; and a processor, wherein theprocessor is configured to: operate in a first mode at a first time,wherein in the first mode the processor is configured to operate anaspect of the controllable jaw according to the default actuationalgorithm; and receive data at a second time, after the first time, thatcauses the processor to operate in a second mode, wherein in the secondmode the processor is configured to operate an aspect of thecontrollable jaw according to an alternative actuation algorithm.
 2. Thepowered surgical end-effector of claim 1, further comprising atransmitter and a receiver configured to establish a communicationpathway between the powered surgical end-effector and an externaldevice.
 3. The powered surgical end-effector of claim 2, wherein thedata received at the second time is from the external device via thereceiver.
 4. The powered surgical end-effector of claim 3, wherein theexternal device is a surgical hub.
 5. The powered surgical end-effectorof claim 3, wherein the external device is a cloud computing system. 6.The powered surgical end-effector of claim 1, wherein the data receivedat the second time relates to procedure information.
 7. The poweredsurgical end-effector of claim 1, wherein the data received at thesecond time relates to supplementary measurements through situationalawareness, hospital inputs, and/or user inputs.
 8. The powered surgicalend-effector of claim 1, wherein the data received at the second timerelates to properties of the tissue.
 9. The powered surgicalend-effector of claim 8, wherein the second mode updates a clamppressure, a hold time, or a fire speed of the aspect of the jaw.
 10. Apowered surgical end-effector, comprising: a controllable jaw configuredto operate on a tissue; an updatable memory having stored therein adefault actuation algorithm; and a processor, wherein the processor isconfigured to determine whether to operate in a first mode or a secondmode, wherein in the first mode the processor is configured to operatean aspect of the law according to the default actuation algorithm, andwherein in the second mode the processor is configured to operate anaspect of the jaw according to an alternative actuation algorithm. 11.The powered surgical end-effector of claim 10, further comprising atransmitter and a receiver configured to establish a communicationpathway between the powered surgical end-effector and an externaldevice.
 12. The powered surgical end-effector of claim 11, wherein theexternal device is a surgical hub.
 13. The powered surgical end-effectorof claim 11, wherein the external device is a cloud computing system.14. The powered surgical end-effector of claim 10, wherein thedetermination on whether to operate in the first mode or the second modeis based on procedure information.
 15. The powered surgical end-effectorof claim 10, wherein the determination on whether to operate in thefirst mode or the second mode is based on supplementary measurementsthrough situational awareness, hospital inputs, and/or user inputs. 16.The powered surgical end-effector of claim 10, wherein the determinationon whether to operate in the first mode or the second mode relates toproperties of the tissue.
 17. The powered surgical end-effector of claim16, wherein the second mode updates a clamp pressure, a hold time, or afire speed of the aspect of the jaw.
 18. A surgical hub, comprising: atransmitter and a receiver configured to establish a communicationpathway between the surgical hub and a powered surgical end-effector,and a processor configured to: determine whether communication isavailable with the powered surgical end-effector that is configured tooperate in a first mode or in a second mode, wherein in the first mode,the powered surgical end-effector operates an aspect of a controllablejaw according to a default actuation algorithm stored in the updatablememory of the powered surgical end-effector; receive data from relatedto the powered surgical end-effector via the receiver; determine whetherthe surgical end-effector should operate in the first mode or the secondmode based on the received data; and based on the determination, sendupdated data that causes the powered surgical end-effector to operate inthe second mode, wherein in the second mode, the powered surgicalend-effector operates the aspect of the controllable law according to analternative actuation algorithm.
 19. The surgical hub of claim 18,wherein the determination whether communication is available isdetermined by an available processing capacity, a memory, a bandwidth, asoftware revision, or a subscription level.
 20. The surgical hub ofclaim 18, wherein the data sent relates to procedure information.